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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/521,949, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The ‘949 application is entirely unrelated to the subject matter of the claimed invention so that it’s indication on the Application Data Sheet and on the first page of the Specification appears to be a typographical error. It appears that the proper priority application is Application No. 17/521,049. In order to properly claim benefit to the ‘049 application, it appears a petition for an unintentionally delayed claim may be required (see MPEP 211.03 and 211.04).
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: it is recommended to amend line 1 to recite “an exterior of a body” to provide antecedent basis to the claim terminology. 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 1 and 2 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 1 recites the limitation "the port protector" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the preamble should be amended to define that the catheter port comprises a port protector or if the preamble should instead be drawn to “A catheter port protector” (similar to the preamble of claim 2). For examination purposes, the second interpretation is used.
Regarding claim 1, the claim recites that a protector body comprises a single “uniform” body. It is unclear what the term “uniform” encompasses – it is unclear if this intends to mean a material property, thickness, or manufacturing process. The specification is devoid of the term “uniform” and therefore fails to guide PHOSITA’s understanding of how the term should be construed. For examination purposes, a single, one-piece body is equated to the term “uniform”.
Claim 1 recites the limitation "said flat rim" in line 5. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the same as the flat rim portion or separate from the flat rim portion. For examination purposes, the first interpretation is used. The examiner notes that “said flat rim” is used consistently throughout the remainder of the claim set. If Applicant intends for the first interpretation to be used, it is recommended to amend the remaining instances to align claim terminology. Additionally, using this interpretation, it is unclear how the flat rim portion extends upwards away from itself. For examination purposes, the claim is interpreted to mean said dome portion extends upwards away from said flat rim portion, as this interpretation appears aligned with applicant’s invention (fig. 1).
Claim 1 recites the limitation "said dome" in line 9. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the same as the dome portion or separate from the dome portion. For examination purposes, the first interpretation is used.
Regarding claim 2, the preamble is drawn to “The catheter port protector of claim 1”; however, claim 1 is drawn to “A catheter port”. It is unclear if claim 2 should be amended to recite “The catheter port” or if claim 1 should be amended to recite “A catheter port protector”. For examination purposes, the second interpretation is used.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1 and 2 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 1, the claim recites “a portion of said adhesive ring is secured against the body”. It is understood that “the body” is in reference towards a human body so that it appears that the claim positively recites the human body. It is recommended to amend the claim to recite that “a portion of said adhesive ring is configured to be secured against the body” to overcome the rejection.
Claim 2 is also rejected by virtue of being dependent on claim 1.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Long (US 20130102945).
Regarding claim 1, Long discloses a catheter port configured to be placed on the exterior of a body, thereby covering a port entering the body (fig. 10B), the port protector comprising:
a protector body (body formed by dome 11 and flange 13 in fig. 6) comprising a single uniform body (fig. 10B shows the dome 11 and flange 13 as a single uniform body, as best understood by the examiner) including both a flat rim portion (flange 13 in fig. 6) and a dome portion (dome 11 in fig. 6) without separation between said flat rim portion and said dome portion (fig. 10B; paragraph 23), whereby said flat rim portion extends upwards away from said flat rim, forming an interior space (see 112(b) rejection/interpretation above; fig. 6 shows dome 11 extending upwards away from flange 13 to form cavity 12);
said flat rim configured to be placed about a catheter insertion site and an associated access port on the exterior of the body at said catheter insertion site (flange 13 in fig. 10B is capable of being placed around a catheter insertion site and associated access port);
an adhesive ring (bandage 30 in fig. 10A/B; paragraph 36 discloses the bandage 30 is adhesive) comprising a hole configured to fit around said dome (fig. 10A; paragraph 36), such that a portion of said adhesive ring is secured about a top face of said flat rim and a portion of said adhesive ring is secured against the body about said catheter insertion site (see below); and
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said interior space configured to be placed around and over said access port with no portion of said protector body being placed within said body (fig. 10B, the cavity 12 is capable of being placed around/over the access port with no portion of the protector body being within the body).
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.
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Long, as applied to claim 1 above, and further in view of Wright (US 20070055205).
Regarding claim 2, Long discloses all of the claimed limitations set forth in claim 1, as discussed above, and further discloses a ring affixed to a bottom face of said flat rim (flange adhesive 17 in fig. 10B), said ring sized to fit said bottom face of said flat rim (paragraph 35 discloses the flange adhesive surrounds the perimeter of the dome 11 substantially coextensive with flange so as to be “sized to fit”).
However, Long does not explicitly teach or disclose the ring being a padded ring.
Wright teaches a similar device (fig. 2) comprising a padded ring connected to a bottom of a flat rim (seal 15 in fig. 2 is disclosed in paragraph 32 as adhering to the skin and providing cushioning to lip 16 so as to be “padded”). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the ring of Long to be a padded ring, as taught by Wright, in order to improve comfort for the wearer (paragraph 32).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM 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, BHISMA MEHTA can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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