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 .
Information Disclosure Statement
The information disclosure statement(s) have been considered by the examiner.
Priority
Priority to provisional application 63/401930 has been acknowledged.
Election/Restrictions
Applicant's election with traverse of Species III in the reply filed on 4/15/2026 is acknowledged. The traversal is on the ground(s) that examiner allegedly failed to properly identify each of the disclosed species because examiner does not use precisely the same language as applicant uses in their claims, and further alleging that there would be no serious search or examination burden to consider the different species of the disclosure because applicant presumes that when searching/examining any of species I-VI that the examiner would encounter the subject matter of the other species. This is not found persuasive because 1) examiners delineation of the species utilizes terms known in the art in a manner that is reasonably interpretable by a person of ordinary skill in the art to convey the key subject matter of the different species of applicants disclosed inventions, and 2) examiner would face a serious search and examination burden if examining each distinct species because each distinct species differs in a number, arrangement, orientation, and position of different tubing/connector/hub elements which would each require distinct and specific text search terms, and adjusting relative relationships of those search terms, to identify art which pertains to these varying species and arrangements of elements. Examiner’s search demonstrates certain arrangements of text search terms which are tailored to the elected species and would require substantial modifications, replacements, rearrangements, and other forms of change of scope to adequately capture and search for the other species of applicant’s disclosure.
Examiner notes that applicant elected Species III, pertaining to figures 10-12, and encompassing subject matter where two parallel lines extend directly from a singular side port in a catheter hub. Applicant indicated that claims 1-5 and 8-18 encompass this embodiment. In examiner’s review of claims 1-5 and 8-18 in light of the elected species, it appears to examiner that only claims 1-3, 8, and 12-14 read on the subject matter of figures 10-12.
Regarding claim 4
Examiner notes that claim 4 is dependent upon claim 3, which is considered to pertain on the embodiment of figure 11 in species III, but not figures 10 or 12. The claim recites the particular claim language of “wherein the near patient access port further comprises a secondary port, and wherein the connector portion of the near patient access port is a needle-free connector.”, which does not pertain to the subject matter of species III, because in the embodiment of figure 11 a near patient access port 26 is not demonstrated as having a connector portion being a needle-free connector 40, nor is the near patient access port 26 of figures 11 demonstrated with a secondary port 32. Accordingly, the subject matter of claim 4 is withdrawn from consideration as pertaining to an unelected species.
Regarding claim 5
Examiner notes that claim 5 is dependent upon claim 4, which as discussed above, pertains to an unelected species and is accordingly withdrawn from consideration as pertaining to an unelected species.
Regarding claim 9
Examiner notes that claim 9 is dependent upon claim 8, which is considered to pertain on the embodiment of figure 11 in species III, but not figures 10 or 12. The claim recites the particular claim language of “wherein the stabilization platform comprises an attachment member configured to secure the stabilization platform to a skin surface of a patient”, which does not pertain to the subject matter of species III, because in the embodiment of figures 11 a stabilization platform 16 is not provided with an attachment member 38. Further none of illustrated inventions of species III in figures 10-12 are demonstrated as possessing an attachment member 38. Accordingly, the subject matter of claim 9 is withdrawn from consideration as pertaining to an unelected species.
Regarding claim 10
Examiner notes that claim 10 is dependent upon claim 9, which as discussed above, pertains to an unelected species and is accordingly withdrawn from consideration as pertaining to an unelected species.
Regarding claim 11
The claim recites the particular claim language of “clamp positioned along at least one of the first line and the second line”, which does not pertain to the subject matter of species III, because in the embodiment of figures 10-12 a clamp 116 is not demonstrated as being positioned along first line 102 or second line 104, rather clamp 116 is distinctly positioned on a third line 114 which is not presently recited in the pending claims. This subject matter appears to pertain to the subject matter of species IIB. Accordingly, the subject matter of claim 11 is withdrawn from consideration as pertaining to an unelected species.
Regarding claim 15
The claim recites the particular claim language of “wherein at least one of the first connector and the second connector comprises a force controlled release connector, and 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”, which does not pertain to the subject matter of species III, because in the embodiment of figures 10-12 a force controlled release connector 50 is not demonstrated as being separable from a proximal access port 24. This subject matter appears to pertain to the subject matter of species I. Accordingly, the subject matter of claim 15 is withdrawn from consideration as pertaining to an unelected species.
Regarding claim 16-18
Examiner notes that claims 16-18 are dependent upon claim 15, which as discussed above, pertains to an unelected species and is accordingly withdrawn from consideration as pertaining to an unelected species.
The requirement is still deemed proper and is therefore made FINAL.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20210228125 A1, henceforth written as Ma.
Regarding claim 1, Ma discloses:
An integrated catheter system comprising:
(catheter assembly 200; fig 2)
a catheter adapter comprising
(catheter adapter 220; fig 2)
a catheter,
(catheter 230; fig 2)
a body receiving the catheter, and
(housing (not enumerated) of catheter adapter 220 is considered the claimed body as the housing (not enumerated) receives catheter 230 at its distal end 222; fig 2 and examiner’s annotation of Ma’s figure 2 below)
a side port in fluid communication with the catheter;
(see examiner's annotation of Ma’s figure 2 denoting the claimed side port in fluid communication with catheter 230; paragraph 22-25+32-33 describe the manner that this side port may be considered in fluid communication with catheter 230 by conveying the fluid contained within tubes 250ab to catheter 230)
a first line in fluid communication with the catheter;
(tube 250a; fig 2))
a second line in fluid communication with the catheter;
(tube 250b; fig 2)
a first connector coupled to the first line; and
(collection port 270; fig 2)
a second connector coupled to the second line.
(infusion port 260; fig 2)
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Examiner’s annotation of Ma’s figure 2
Regarding claim 3, Ma discloses:
The system of claim 1, wherein the first line comprises a near patient access port in fluid communication with the side port of the catheter adapter
(the opening (not enumerated) of blood collection port 270 can be considered a near patient access port in that it is indirectly connected to a catheter 230 which is to be disposed within a patient such that through this indirect connection the blood collection port 270 could be considered proximate – or near – a patient for access by a user of the invention; see examiner’s annotation of Ma’s figure 2 above denoting the claimed opening)
, the near patient access port comprising a connector portion configured to be coupled to a peripheral probe device.
(claim language of “configured to” implies a functional language and the prior art must at least be capable of performing the recited function of being couple to a peripheral probe device, and considering port 270 is a connector of a certain type and being connected to a inner lumen of tube 250a of a certain inner diameter it is functionally capable of coupling to a peripheral probe device having a matching connector type and a probe of an outer diameter smaller than the inner diameter of tube 250a)
Regarding claim 13, Ma discloses:
The system of claim 1, wherein the catheter adapter comprises a pair of catheter adapter stabilizing wings.
(see examiner's annotation of Ma's figure 2, above, denoting the elements of catheter adapter 220 considered the claimed pair of catheter adapter stabilizing wings)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ma, as applied to claims above, in view of CN 109498890 A, henceforth written as Fu.
Regarding Claim 2,
Ma discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Ma is silent regarding:
wherein the first connector and the second connector each comprise a needle-free connector.
However, Fu teaches an advantageous form of needle free connector, see invention of Fu’s figure 3-4, which is suitable for both blood collection and infusion of medicaments, see paragraph 32-37, in that it prohibits backflow of blood into the catheter lumen and reduces an amount drug infusion which forms as residue within the connector, see paragraph 34 and 36-37.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to substitute the type of blood collection and infusion ports disclosed by Ma with the type of needle-free connector taught by Fu, such that the first connector and second connector of the modified invention each compress needle-free connectors, in order to advantageously arrive at an invention which reduces a risk of blood backflow into a catheter lumen and thus associated risks of blood clots being introduced into a patient, see paragraph 34 of Fu, which can reduce an amount of infused drug reside in a connector, see paragraph 36-37 of Fu, and which can infuse medicament or collect blood from either of its catheter hub side port connectors.
Claims 8, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ma, as applied to claims above, in view of US 20160206856 A1, henceforth written as Watson.
Regarding Claim 8,
Ma discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Ma is silent regarding:
a stabilization platform spaced from the body of the catheter adapter and positioned along the first line or the second line.
However, Watson teaches a fastener for securing a fluid line comprising:
a stabilization platform spaced from [a connector] and positioned along the first line or the second line.
(paragraph 2+58-60; fastener 200 can be considered the claimed stabilization platform in that it has a sleeve 210 for being positioned along a fluid line such that sleeve 210 can hold a tube adjacent the patient’s skin, therein a platform acting to stabilize the tubing; fig 3-5; fig 12 best demonstrates the manner that the fastener 200 of fig 3-5 may be disposed in a position along a fluid space from a connector, illustrated by figure 12’s embodiment of a fastener sleeve 610 spaced from connectors 614 616)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, incorporate the stabilization platform taught by Watson to the fluid lines of Ma, such that each of Ma’s first line and second line have Watson’s fastener 200, in order to advantageously arrive at an invention which can stabilize the position of its peripheral fluid conveying tubes relative to a patient, see paragraph 58 of Watson, and audibly indicate to an operator when the invention is actively stabilizing a tube, see paragraph 60 of Watson.
Regarding claim 12, the modified invention of Ma in view of Watson teaches:
The system of claim 8, wherein the stabilization platform comprises a pair of stabilizing wings.
See examiner’s annotation of Watson’s figure 4 demonstrating the portions of the Watson’s fastener 200’s stable attachment plate 226 considered the pair of stabilizing wings.
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Regarding claim 14, the modified invention of Ma in view of Watson teaches
The system of claim 8, wherein the stabilization platform is moveable along the first line or the second line.
Examiner notes that in light of the modification of Ma in view of Watson above, the fasteners 200 of Watson are moveable along Ma’s tubes 250a as Watson’s sleeve 210 may be widened by an operator to release a tube and permit an operator to adjust the position of sleeve 210 relative to the tube, see paragraph 56-57 of Watson.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure, particularly subject matter of the independent claim(s) and the elected species pertaining to two parallel lines extending directly from a singular side port in a catheter hub:
US 20120029479 A1
US 20200324100 A1
US 5350358 A
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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