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 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 3-8 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.
In claims 3 and 6, Applicant requires “a fluid reservoir”, it is unclear how such is related to “a fluid reservoir” in claim 1. This also results in it being unclear to which fluid reservoir “the fluid reservoir” such as in claim 4 (among others) is meant to reference.
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) 1-5 and 9-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Avula et al (US 2019/0099593).
Regarding claim 1, Avula discloses a disinfection cap (title) having a housing 150 comprising: a cylindrical sidewall having an inner surface defining a cavity 155 and a top wall (right/bottom of fig 4A), an open bottom (left/top of fig 4A) formed by the cylindrical sidewall with an opening to the cavity within said housing for receiving a hub of a luer connector (capable of such); a corrugated capsule 110 (fig 2A) disposed within the cavity (fig 4A), the corrugated capsule having a proximal surface, a distal surface and an elongated body between the proximal surface and distal surface (figs 4A and 4B), the distal surface of the corrugated capsule abutting the top wall of the cavity (fig 4A), the corrugated capsule having a fluid reservoir 113 (¶35); and, a disinfectant disposed within the fluid reservoir (¶37), the disinfectant being retained within the fluid reservoir in an initial state, wherein the hub of said luer connector is received within said inner surface of said cavity (device is capable of such).
Regarding claim 2, the elongated body further comprising at least one corrugation configured to collapse on one another upon application of pressure on the proximal surface due to insertion of the hub into the cavity of the housing (fig 4A).
Regarding claim 3, the corrugated capsule further comprising a slit 117 in fluid communication with a fluid reservoir, the slit being disposed on the proximal surface of the corrugated capsule (fig 4B).
Regarding claim 4, wherein in an initial, uncompressed state, the slit is fluidly closed, the fluid reservoir retaining disinfectant due to negative pressure within the fluid reservoir (fig 2A).
Regarding claim 5, wherein upon compression of the elongated body due to insertion of the hub of the luer connector, the at least one corrugation collapses on one another causing a pressure buildup within the fluid reservoir, the pressure buildup causing the slit to deform and open, causing disinfectant to eject from the slit, disinfecting the hub and a periphery of the luer connector (fig 4A; ¶38).
Regarding claim 9, the distal surface of the corrugated capsule further comprising an aperture 116 extending through the distal surface (fig 2A).
Regarding claim 10, wherein the proximal surface of the corrugated capsule is an open proximal surface (fig 2A).
Regarding claim 11, further comprising an end cap abutting an engagement surface of the open proximal surface (fig 4A).
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) 6-8, 12, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Avula et al (US 2019/0099593).
Regarding claim 6, while Avula substantially discloses the invention as claimed, it does not disclose the corrugated capsule further comprising a plurality of perforations in fluid communication with a fluid reservoir, the plurality of perforations being disposed on the elongated body of the corrugated capsule.
Avula discloses a perforation 117 in fluid communication with the reservoir (fig 2A) and disposed on the elongated body of the corrugated capsule (fig 2A).
Avula also discloses other release openings/points are within the scope of the invention (¶44).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Avula such that the single perforation comprises a plurality of perforations both to allow for faster dispensing and since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 7, wherein in an initial, uncompressed state, the plurality of perforations are fluidly closed, the fluid reservoir retaining disinfectant due to negative pressure within the fluid reservoir (see modification in claim 6 and fig 2A).
Regarding claim 8, wherein upon compression of the elongated body due to insertion of the hub of the luer connector, the at least one corrugation collapses on one another causing a pressure buildup within the fluid reservoir, the pressure buildup causing the plurality of perforations to deform and open, causing disinfectant to eject from the plurality of perforations, disinfecting the hub and a periphery of the luer connector (see modification in claim 6 and fig 4A).
Regarding claim 12, while Avula substantially discloses the invention as claimed, it does not disclose wherein the end cap comprises a plurality of apertures, the plurality of apertures configured to be disposed around a periphery of the end cap.
Avula also discloses other release openings/points are within the scope of the invention (¶44).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Avula such that the end cap comprises a plurality of apertures, the plurality of apertures configured to be disposed around a periphery of the end cap as both duplication of parts and rearrangement of parts are considered obvious modifications within ordinary skill.
Regarding claim 14, wherein in an initial, uncompressed state, the plurality of apertures are configured to not excrete disinfectant due to negative pressure within the fluid reservoir (¶37).
Regarding claim 15, wherein in a final, compressed state, buildup of pressure causes disinfectant to excrete through the plurality of apertures, disinfecting the hub and the periphery of the luer connector (¶37, ¶38).
Claim(s) 13, 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Avula et al (US 2019/0099593) in view of Solomon et al (US 8,172,825).
Regarding claim 13, while Avula substantially discloses the invention as claimed, it does not disclose wherein the plurality of apertures are positioned a distance away from a center of the end cap as to not direct fluid flow into a lumen of the hub of the luer connector.
Solomon discloses a disinfection cap with a collapsible element 2270 impregnated with a disinfectant (fig 37, similar to corrugated capsule). It utilizes a piston 2290 with ports 2294 such that an inserted luer has its center bore sealed and the exterior of the tip has the disinfectant directed upon it (fig 39).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Avula such that the plurality of apertures are positioned a distance away from a center of the end cap as to not direct fluid flow into a lumen of the hub of the luer connector as taught by Solomon so as to direct the disinfectant to a desired location and prevent it from entering an undesired location.
Regarding claim 16, Avula discloses a disinfection cap (title) having a housing 150 comprising: a cylindrical sidewall having an inner surface defining a cavity 155 and a top wall (right/bottom of fig 4A), an open bottom (left/top of fig 4A) formed by the cylindrical sidewall with an opening to the cavity within said housing for receiving a hub of a luer connector (capable of such); a corrugated capsule 110 (fig 2A) having a proximal surface disposed within the cavity (fig 4A), the corrugated capsule having a proximal end, a closed distal end (fig 7A shares the same elements as the rest of that in fig 2A, but also has a seal member 419 closing the distal end) and an elongated body between the proximal end and distal end (figs 4A and 4B), the distal end of the corrugated capsule abutting the top wall of the cavity (fig 4A), the corrugated capsule having a fluid reservoir 113 (¶35); and, a disinfectant disposed within the fluid reservoir (¶37), the disinfectant being retained within the fluid reservoir in an initial state, wherein the hub of said luer connector is received within said inner surface of said cavity (device is capable of such).
While Avula substantially discloses the invention as claimed, it does not disclose the proximal end is open, nor a piston disposed against the open proximal end.
Solomon discloses a disinfection cap with a collapsible element 2270 impregnated with a disinfectant (fig 37, similar to corrugated capsule). It utilizes a piston 2290 with ports 2294 such that an inserted luer has its center bore sealed and the exterior of the tip has the disinfectant directed upon it (fig 39).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Avula such that the proximal end is open and it includes a piston disposed against the open proximal end as suggested by Solomon to direct fluid against the exterior of the inserted tip while sealing the center bore.
Regarding claim 17, the elongated body further comprising at least one corrugation configured to collapse on one another upon application of pressure on the proximal surface due to insertion of the hub into the cavity of the housing (fig 4A).
Allowable Subject Matter
Claims 18-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The examiner did not find a teaching or suggestion for modifying closest art Avula in view of Solomon such that the piston has a proximal portion equal or larger than a diameter of the capsule and a diameter of a distal portion is less than or equal to that of the fluid reservoir to be positioned within the corrugated capsule to create a liquid tight seal, in addition to the other limitations, absent impermissible hindsight.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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, Michael Tsai can be reached at (571)270-5246. 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.
/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
Prosecution Insights