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 .
Specification
The abstract of the disclosure is objected to because:
In line 5, “the circumference” should be changed to “a circumference”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-3 and 5-7 are objected to because of the following informalities:
In regards to claim 1, line 9, “the body” should be changed to “the body of the adhesive member”.
In regards to claim 1, lines 9-10, “the circumference” should be changed to “a circumference”.
In regards to claim 1, line 10, “an implanted port” should be changed to “the implanted port”.
In regards to claim 2, line 1, “the cap’s body” should be changed to “the body of the cap”.
In regards to claim 3, line 1, “an angle” should be changed to “the angle”.
In regards to claim 5, line 10, “the body” should be changed to “the body of the adhesive member”.
In regards to claim 5, lines 10-11, “the circumference” should be changed to “a circumference”.
In regards to claim 5, line 11, “an implanted port” should be changed to “the implanted port”.
In regards to claim 6, line 1, “the cap’s body” should be changed to “the body of the cap”.
In regards to claim 7, line 8, “an implanted port” should be changed to “the implanted port”.
In regards to claim 7, line 12, “the body” should be changed to “the body of the adhesive member”.
In regards to claim 7, line 13, “the circumference” should be changed to “a circumference”.
In regards to claim 7, line 13, “an implanted port” should be changed to “the implanted port”.
In regards to claim 7, line 26, “an implanted port” should be changed to “the implanted port”.
In regards to claim 7, line 26, “the user’s skin” should be changed to “skin of a user”.
In regards to claim 7, line 32, “the user’s skin” should be changed to “the skin of the user”.
In regards to claim 7, line 34, “the access cap port system” should be changed to “the access port cap system”.
Appropriate correction is required.
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 and 5-6 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 regards to claim 3, line 2, the term “approximately 45-degrees” is a relative term which renders the claim indefinite. The term “approximately 45-degrees” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
In regards to claim 5, lines 7-8, the term “approximately 45-degrees” is a relative term which renders the claim indefinite. The term “approximately 45-degrees” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 6 is rejected by virtue of being dependent upon claim 5.
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 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crain (US 2022/0143381).
In regards to claim 1, Crain teaches an access port cap system (Figures 1-7, protector device 2), comprising:
a cap (4/6/12), the cap having:
a body (6) forming an interior reservoir (12) therein
a perimeter lip (4) extending from a base of the body
wherein the interior reservoir is configured to provide clearance between the body and a top portion of an implanted port (Figures 2-3, 7)
wherein the perimeter lip extends at an angle (labeled in Figure 7 below) for ease of removal
an adhesive member (8), the adhesive member having:
a body (8) forming an opening (Figure 2) therein, the body configured to surround the circumference of an implanted port (Figures 1-3)
a double-sided adhesive tape (8) having a top sticky layer and a bottom sticky layer (paragraph [0023]: The adhesive 8 could be… a double-sided tape disc), the double-sided adhesive tape contained between a top release liner and a bottom release liner (10) (While Crain does teach a bottom release liner (10) attached to the bottom sticky layer (Figure 2), Crain does not explicitly disclose a top release liner attached to the top sticky layer. However, it is noted that claim 1 is drawn to an access port cap system, wherein a top release liner and a bottom release liner are not positively recited structures of the claimed access port cap system. Crain teaches the claimed access port cap system of claim 1 which has the ability to be used with a top release liner and a bottom release liner, as claimed, as the structure of the double-sided adhesive tape (8), as a separate component from the cap (4/6/12) (Figure 2), is capable of being contained between a top release liner and a bottom release liner; thus anticipating said claim limitation)
wherein, upon removal of the top release liner, the perimeter lip adheres to the top sticky layer of the double-sided adhesive tape (Figure 1)
wherein, upon removal of the bottom release liner, the bottom sticky layer of the double-sided adhesive tape is positioned around the circumference of the implanted port, thereby placing the cap over the implanted port (Figure 3)
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In regards to claim 2, Crain teaches wherein the cap's body is dome-shaped (6).
In regards to claim 3, Crain teaches wherein the perimeter lip extends at an angle (labeled in Figure 7 above) measured approximately 45-degrees (Figure 7).
In regards to claim 4, Crain teaches wherein the double-sided adhesive tape is composed of medical grade double sticky tape (paragraph [0023]: The adhesive 8 could be… a double-sided tape disc).
In regards to claim 5, Crain teaches an access port cap system (Figures 1-7, protector device 2), comprising:
a cap (4/6/12), the cap having:
a body (6) forming an interior reservoir (12) therein
a perimeter lip (4) extending from a base of the body
wherein the interior reservoir is configured to provide clearance between the body and a top portion of an implanted port (Figures 2-3, 7)
wherein the perimeter lip extends at an angle (labeled in Figure 7 above) measured approximately 45-degrees for ease of removal (Figure 7)
an adhesive member (8), the adhesive member having:
a body (8) forming an opening (Figure 2) therein, the body configured to surround the circumference of an implanted port (Figures 1-3)
a double-sided adhesive tape (8) having a top sticky layer and a bottom sticky layer (paragraph [0023]: The adhesive 8 could be… a double-sided tape disc), the double-sided adhesive tape contained between a top release liner and a bottom release liner (10) (While Crain does teach a bottom release liner (10) attached to the bottom sticky layer (Figure 2), Crain does not explicitly disclose a top release liner attached to the top sticky layer. However, it is noted that claim 5 is drawn to an access port cap system, wherein a top release liner and a bottom release liner are not positively recited structures of the claimed access port cap system. Crain teaches the claimed access port cap system of claim 5 which has the ability to be used with a top release liner and a bottom release liner, as claimed, as the structure of the double-sided adhesive tape (8), as a separate component from the cap (4/6/12) (Figure 2), is capable of being contained between a top release liner and a bottom release liner; thus anticipating said claim limitation)
wherein the double-sided adhesive tape is composed of medical grade double sticky tape (paragraph [0023]: The adhesive 8 could be… a double-sided tape disc)
wherein, upon removal of the top release liner, the perimeter lip adheres to the top sticky layer of the double-sided adhesive tape (Figure 1)
wherein, upon removal of the bottom release liner, the bottom sticky layer of the double-sided adhesive tape is positioned around the circumference of the implanted port, thereby placing the cap over the implanted port (Figure 3)
In regards to claim 6, Crain teaches wherein the cap's body is dome-shaped (6).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Crain, and further in view of McGee (US 2008/0047664) and Shultz (US 12,109,318). Note: the cited subject matter of Shultz (US 12,109,318) is applicable as supported in earlier-filed US 17/694,312, filed on March 14, 2022, and US 63/209,450, filed on June 11, 2021, before the effective filing date of Applicant’s claimed invention of July 20, 2022.
In regards to claim 7, Crain teaches a method for preventing pain when an implanted port is accessed (paragraph [0002]: The present invention relates generally to a port protector and cover system and method for use thereof, and more specifically to a cover and protector for port catheter devices installed in patients which serve to prevent creams and lidocaine from leaking away from the porta catheter site and to prevent pain and discomfort associated with bumping or snagging objects and clothing), the method comprising:
providing an access port cap system (Figures 1-7, protector device 2), the access port cap system comprising:
a cap (4/6/12), the cap having:
a body (6) forming an interior reservoir (12) therein
a perimeter lip (4) extending from a base of the body
wherein the interior reservoir is configured to provide clearance between the body and a top portion of an implanted port (Figures 2-3, 7)
wherein the perimeter lip extends at an angle (labeled in Figure 7 above) for ease of removal
an adhesive member (8), the adhesive member having:
a body (8) forming an opening (Figure 2) therein, the body configured to surround the circumference of an implanted port (Figures 1-3)
a double-sided adhesive tape (8) having a top sticky layer and a bottom sticky layer (paragraph [0023]: The adhesive 8 could be… a double-sided tape disc)
wherein, the perimeter lip adheres to the top sticky layer of the double-sided adhesive tape (Figure 1)
wherein, upon removal of the bottom release liner (10), the bottom sticky layer of the double-sided adhesive tape is positioned around the circumference of the implanted port, thereby placing the cap over the implanted port (Figures 2-3)
adhering the perimeter lip to the exposed top sticky layer (Figure 2 to Figure 1)
topically applying a relatively thick layer of a numbing agent over a raised portion of an implanted port within the user's skin (Abstract: lidocaine applied to the site of the porta catheter)
removing the bottom release liner to expose the bottom sticky layer of the double- sided adhesive tape (Figure 2)
positioning the exposed bottom sticky layer around the circumference of the implanted port, thereby placing the cap over the implanted port, and by extension, the numbing agent (Figure 3)(paragraph [0022]: A dome 6 rises up away from the flat rim 4, forming an interior space 12 for protecting the access port 16 and which may contain… lidocaine)
While Crain does teach a bottom release liner (10) attached to the bottom sticky layer (Figure 2), Crain does not explicitly disclose a top release liner attached to the top sticky layer, resulting in the double-sided adhesive tape contained between a top release liner and a bottom release liner. And thus Crain also does not teach removal of the top release liner and removing the top release liner to expose the top sticky layer of the double-sided adhesive tape. McGee teaches a method comprising: an adhesive member (1) having: a double-sided adhesive tape (1) having a top sticky layer (2) and a bottom sticky layer (3), the double-sided adhesive tape contained between a top release liner (5) and a bottom release liner (paragraph [0028]: protective release liner), removal of the top release liner (paragraph [0030]: liner 5 is removed), and removing the top release liner to expose the top sticky layer of the double-sided adhesive tape (paragraph [0030]: liner 5 is removed to expose the adhesive coating of top side 2). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method, of Crain, with a top release liner, resulting in the double-sided adhesive tape contained between a top release liner and a bottom release liner, removal of the top release liner, and removing the top release liner to expose the top sticky layer of the double-sided adhesive tape, as taught by McGee, as such will protect the top sticky layer, until a second surface is required to be bonded, and this is accomplished by first removing the top release liner from the top sticky layer of the tape and then bonding the top sticky layer of the tape to the second surface (paragraph [0003]).
Further, while Crain teaches the numbing agent (Abstract: lidocaine), Crain is silent about allowing the user's skin to absorb the numbing agent for a predetermined amount of time. And Crain is silent about removing the access cap port system to allow the implanted port to be accessed. Shultz teaches a method for preventing pain when an implanted port is accessed, the method comprising: allowing a user's skin to absorb a numbing agent for a predetermined amount of time (column 22, lines 54-60: Generally, the patient leaves the device over the port site for a sufficient period of time to numb the port site, typically about 10 minutes to an hour... During this time, the medication in the compartment is in contact with the port site), and removing an access cap port system to allow the implanted port to be accessed (column 22, lines 61-62: Immediately prior to accessing the implanted port, the device is removed from the patient's skin). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method, of Crain and McGee, with allowing the user's skin to absorb the numbing agent for a predetermined amount of time, and removing the access cap port system to allow the implanted port to be accessed, as taught by Shultz, as such will allow for managing chronic illness, such as cancer and autoimmune and neurological disorders by the implanted port allowing medical professionals easy, reliable access to administer medicine, vitamins, and/or other necessary liquids to a patient directly into the veins and allowing medical professionals the ability to withdraw blood from a patient for labs easier and generally more comfortable for the patient than multiple needle sticks (column 1, lines 21-35).
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783