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 with traverse of Species I (Figure 1) of a catheter system and Species I (Figure 5) of a stabilization anchor platform and an attachment member in the reply filed on August 18, 2026, is acknowledged.
The traversal is on the ground(s) that: Although the Requirement asserts that the identified species are distinct and not obvious variants of each other, the Requirement does not establish how examination of the identified species would result in a serious burden being imposed through examination. The mere identification of different catheter- system configurations or different attachment-member forms does not, by itself, demonstrate that the claims would require materially different searches or examinations. Applicant respectfully contends that, when searching for a catheter system having a stabilization anchor platform integrated with extension tubing, one would reasonably be expected to find catheter systems having a stabilization anchor platform integrated with other tubing or components of the catheter system. For example, a search directed to the elected catheter-system species would reasonably involve consideration of stabilization anchor platforms integrated with extension tubing, intermediate tubing, a near-patient access port, a proximal access port, a clamp, or a force controlled release connector. Accordingly, searching for the elected catheter-system species would reasonably involve consideration of the other catheter-system species identified in the Requirement. Applicant further respectfully contends that the Specification describes the identified catheter-system species as alternative configurations of the same catheter system having a stabilization anchor platform. Specifically, the Specification describes the stabilization-anchor- platform as being integrated with tubing or with components of the catheter system, including extension tubing, intermediate tubing, a near-patient access port, a proximal access port, and a force controlled release connector. These configurations are used for the same purpose of securing the stabilization anchor platform in place relative to the skin surface and reducing movement or dislodgement of the catheter system. Accordingly, the identified catheter-system species represent alternative stabilization-anchor-platform configurations within the same catheter system rather than distinct inventions requiring materially different searches or examinations. With respect to the stabilization-anchor-platform/attachment-member species, Applicant respectfully contends that, when searching for an attachment-member comprising an upper securement member positioned over the stabilization anchor platform, one would reasonably be expected to find other attachment-members for securing the stabilization-anchor-platform in place relative to the skin surface. For example, a search directed to the elected attachment-member species would reasonably involve consideration of an upper securement member, an external stabilization device, a pattern or layer of adhesive, or combinations thereof. Accordingly, searching for the elected attachment-member species would reasonably involve consideration of the other attachment-member species identified in the Requirement. Applicant further respectfully contends that the Specification describes the identified attachment-member species as alternative forms of attachment-members for securing the same stabilization anchor platform in place relative to the skin surface. Specifically, the Specification describes the attachment-member as including securement tape, an external stabilization device, a dressing, an anchor platform adhesive with paper backing, and/or a skin adhesive. The Specification also describes attachment-member embodiments that include both an upper securement member and an external stabilization device, and embodiments that include both an upper securement member and a pattern or layer of adhesive. Accordingly, the identified attachment-member species represent alternative and, in some instances, combinable securement structures for the same stabilization anchor platform rather than distinct inventions requiring materially different searches or examinations (Remarks, pages 3-5).
This is not found persuasive because there is a serious search and/or examination burden because the claims to the different species recite mutually exclusive characteristics for each identified species requiring a search of recognized divergent subject matter, different classes/subclasses or electronic resources, and different search strategies or search queries.
The requirement is still deemed proper and is therefore made FINAL.
Applicant identified claims 1, 5, 11-13, and 18-19 encompassing the elected species.
Claims 2-4, 6-10, 14-17, and 20-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 18, 2026.
However, claim 13 does not encompass the elected species.
Claim 13 at least recites “A non-integrated catheter system comprising: a catheter hub; a non-integrated extension set comprising: a catheter connector including a side port in fluid communication with the catheter; and extension tubing having a proximal access port”, which do not encompass elected Species I (Figure 1) of a catheter system. Thus, claim 13 is withdrawn from further consideration as being drawn to nonelected species. And claims 18-19 are withdrawn from further consideration by virtue of being dependent upon withdrawn claim 13.
Thus, claims 1, 5, and 11-12 are under examination as encompassing the elected species.
Specification
The abstract of the disclosure is objected to because:
In lines 1-2, “associated catheter device” should be changed to “an associated catheter device”
In line 3, “Extension tubing” should be changed to “An extension tubing”
In line 5, “tubing” should be changed to “a tubing”
In line 6, “tubing” should be changed to “the tubing”
In lines 8-9, “intermediate tubing, extension tubing, proximal access port, or force controlled release connector” should be changed to “an intermediate tubing, the extension tubing, the proximal access port, or a force controlled release connector”
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 and 11 are objected to because of the following informalities:
In regards to claim 1, line 4, “intermediate tubing” should be changed to “an intermediate tubing”.
In regards to claim 1, line 6, “thereon” should be changed to “on the near-patient access port”.
In regards to claim 1, line 7, “extension tubing” should be changed to “an extension tubing”.
In regards to claim 1, line 8, “the catheter device” should be changed to “the catheter adapter”.
In regards to claim 1, line 9, “thereof” should be changed to “of the extension tubing”.
In regards to claim 11, line 5, “therein” should be changed to “in the external stabilization device”.
In regards to claim 11, line 6, “layer” should be changed to “a layer”.
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 11-12 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 11, lines 4-5 recite: “including an adhesive on a bottom surface thereof”. It is unclear which claim element is referred to by the term “thereof”, such that is it unclear which claim element has a bottom surface having an adhesive. Claim 12 is rejected by virtue of being dependent upon claim 11.
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, 5, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkholz et al (US 2019/0321599).
In regards to claim 1, Burkholz et al teaches an integrated catheter system (Figures 1A-1J) comprising:
a catheter adapter (12) for receiving a catheter and including a side port (at 16) in fluid communication with the catheter (Figure 1B)
a near-patient access port (34) coupled to the side port via intermediate tubing (40) and in fluid communication with the side port (Figure 1B), the near-patient access port including a secondary port (at 26) thereon
extension tubing (24) coupled to the secondary port and in fluid communication with the side port of the catheter device via the near-patient access port (Figure 1B), the extension tubing having a proximal access port (30) coupled to a proximal end portion thereof
a stabilization anchor platform (55) integrated with a component of the integrated catheter system and configured to retain the component in place relative to a skin surface of a patient (paragraph [0057]), the component comprising one of the near-patient access port, the intermediate tubing, the extension tubing, or the proximal access port (Figure 1D)
In regards to claim 5, Burkholz et al teaches wherein the stabilization anchor platform is integrated with the extension tubing (Figure 1D).
In regards to claim 11, Burkholz et al teaches an attachment member for securing the stabilization anchor platform relative to the skin surface of the patient, wherein the attachment member comprises one or more of an upper securement member (62) positioned over the stabilization anchor platform (Figure 1H) and including an adhesive (56) on a bottom surface thereof (Figure 1E), an external stabilization device (58) including a cut-out portion formed therein configured to receive the stabilization anchor platform (Figures 1F-1G), and a pattern or layer of adhesive (56) that adheres the stabilization anchor platform directly to the skin surface (Figure 1E).
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al, as applied to claim 11 above, and further in view of Wine et al (US 2023/0211071).
In regards to claim 12, Burkholz et al teaches a force controlled release connector (48) coupled to the proximal access port (Figure 1C), wherein at least a portion of the force controlled release connector is configured to separate from the proximal access port when a predetermined separation force is applied to the force controlled release connector (Figure 1A-1B, 1D, 1F, 1H-1J); however, Burkholz et al is silent about wherein the attachment member retains the stabilization anchor platform in place relative to the skin surface with a securement force that is greater than the predetermined separation force that causes the force controlled release connector to separate from the proximal access port. Wine et al teaches an integrated catheter system (Figure 16), wherein an attachment member (28) retains a stabilization anchor platform (1100) in place relative to a skin surface with a securement force that is greater than a predetermined separation force that causes a force controlled release connector (2100) to separate from a proximal access port (115) (paragraph [0104]). 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 system, of Burkholz et al, with wherein the attachment member retains the stabilization anchor platform in place relative to the skin surface with a securement force that is greater than the predetermined separation force that causes the force controlled release connector to separate from the proximal access port, as taught by Wine et al, as such will configure the force controlled release connector to disconnect the fluid pathway if the stabilization anchor platform becomes separated from the patient due to a force caused by pulling (paragraph [0104]) which will prevent injury to a patient or a caregiver, such as by depriving the patient of a medicament, increasing the potential for infection to the patient, and exposing the caregiver to harmful medicaments (paragraph [0005]).
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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