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 .
Acknowledgments
In the reply, filed on January 8, 2026, Applicant amended claims 1, 3, 6-8, 11-12, and 14-20.
Applicant cancelled claim 13.
In the non-final rejection of October 16, 2025, Examiner noted that the information disclosure statement filed April 7, 2023 (37 pages), fails to comply with 37 CFR 1.98(a)(2). Applicant did not address this concern in the reply. Concern is maintained.
Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 1, 7-8, 11-14, and 16-19. Applicant amended claims 1, 7-8, 11-12, 14, and 16-19, and cancelled claim 13; however, Applicant did not address all of the objections. Objection is maintained.
Examiner rejected claims 6, 18, and 20 under 35 U.S.C. 112(b). Applicant amended claims 6, 18, and 20; however, Applicant did not address all of the rejections. Rejection is maintained.
Currently, claims 1-12 and 14-20 are under examination.
Information Disclosure Statement
The information disclosure statement filed April 7, 2023 (37 pages), fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered:
A copy of Written Opinion for PCT/US2021/035232 has not been provided; however, a copy of International Search Report for PCT/US2021/035232 has been provided
Claim Objections
Claims 1, 11, 16, and 20 are objected to because of the following informalities:
In regards to claim 1, lines 13-14, “second open distal end” should be changed to “the second open distal end”.
In regards to claim 11, line 1, “comprising;” should be changed to “comprising:”.
In regards to claim 16, line 2, “a bone” should be changed to “the bone”.
In regards to claim 20, line 1, “extracting” should be changed to “the extracting”.
In regards to claim 20, line 2, “a first bodily liquid” should be changed to “the first bodily liquid”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 and 14-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 1, lines 15-16 recite: “wherein the frame defines a fixed distance between the first lumen and the second lumen”; however, such is new matter not described in the Specification. Claims 2-10 are rejected by virtue of being dependent upon claim 1.
In regards to claim 3, lines 1-3 recite: wherein the open distal end of the second lumen is spaced longitudinally “along the cavity” away from the open distal end of the first lumen; however, such is new matter not described in the Specification.
In regards to claim 11, lines 9-10 recite: “wherein a distance between the first lumen and the second lumen is defined by a frame of the intraosseous port”; however, such is new matter not described in the Specification. Claims 12 and 14-20 are rejected by virtue of being dependent upon claim 11.
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.
Claim 20 is 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 20, lines 2-3, the term “about 50 ml/min” is a relative term which renders the claim indefinite. The term “about 50 ml/min” 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 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, 4-5, 7, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aklog et al (US 10,426,940).
In regards to claim 1, Aklog et al teaches an intraosseous port (Figure 19), comprising:
a frame (1800/1804) configured for subcutaneous placement within a patient, the frame comprising:
a proximal portion having first cavity (labeled in Figure 19 below) and a second cavity (labeled in Figure 19 below), the first cavity and the second cavity configured for fluidly coupling with a medical system (1900)
a distal portion configured for insertion through a bone wall (Figure 19), the distal portion including:
a first lumen (labeled in Figure 19 below) extending along the distal portion between the first cavity and an open distal end of the first lumen (Figure 19)
a second lumen (labeled in Figure 19 below) extending along the distal portion between the second cavity and an open distal end of the second lumen (Figure 19), wherein the first open distal end and second open distal end are configured for placement within a cavity (1816) of a bone, wherein the frame defines a fixed distance between the first lumen and the second lumen (Figure 19)
an anchoring mechanism (labeled in Figure 19 below) configured for securing the frame to the bone (Figure 19)
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In regards to claim 4, Aklog et al teaches wherein the second cavity is disposed laterally with respect to the first cavity (Figure 19).
In regards to claim 5, Aklog et al teaches wherein the second lumen is disposed laterally with respect to the first lumen (Figure 19).
In regards to claim 7, Aklog et al teaches a first septum (labeled in Figure 19 above) extending across a proximal opening of the first cavity (Figure 19); and a second septum (labeled in Figure 19 above) extending across a proximal opening of the second cavity (Figure 19), wherein the first septum and the second septum are configured for passage of a needle therethrough (Figure 19).
In regards to claim 10, Aklog et al teaches wherein the bone wall includes a humerus (column 10, lines 38-41); however, Aklog et al does not specifically teaches wherein the bone wall includes “a greater tubercle of” a humerus. But it is noted that claim 10 is drawn to an intraosseous port intended to be inserted through a bone wall includes a greater tubercle of a humerus, and thus the bone wall including the greater tubercle of the humerus is not a positively recited structure of the claimed intraosseous port. Aklog et al teaches the claimed intraosseous port of claim 10 which has the ability to be used with a bone wall including a greater tubercle of a humerus, as claimed, wherein the intraosseous port, of Aklog et al, is capable of being inserted through the bone wall including the greater tubercle of the humerus, as claimed.
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.
Claims 2-3, 6, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al, as applied to claim 1 above.
In regards to claim 2, Aklog et al (Figure 19) is silent about wherein the anchoring mechanism includes external threads. Aklog et al teaches another intraosseous port (Figures 6B-6C) wherein an anchoring mechanism includes external threads (606). 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 anchoring mechanism, of the port of Aklog et al (Figure 19), to include external threads, as taught by Aklog et al (Figures 6B-6C), as such will lodge into the cortex layer, which allows the port to be screwed into place with an appropriate instrument (column 9, lines 4-6)(column 11, lines 55-58).
In regards to claim 3, Aklog et al (Figure 19) does not teach wherein the open distal end of the second lumen is spaced longitudinally along the cavity away from the open distal end of the first lumen, as Aklog et al (Figure 19) instead teaches wherein the open distal end of the second lumen is spaced at the same longitudinal position along the cavity as the open distal end of the first lumen (Figure 19). Aklog et al teaches another intraosseous port (Figures 4B-4C) wherein an open distal end (404) of a second lumen (Figure 4C) is spaced longitudinally along a cavity (406) away from an open distal end (404) of a first lumen (Figure 4B). 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 open distal end of the second lumen, of the port of Aklog et al (Figure 19), to be spaced longitudinally along the cavity away from the open distal end of the first lumen, as taught by Aklog et al (Figures 4B-4C), as such will allow for accommodating for different cortical thicknesses and bone marrow cavity diameters (column 8, lines 45-47).
In regards to claim 6, in the modified port of Aklog et al, Aklog et al (Figure 19) is silent about wherein the external threads include a first threaded portion surrounding the first lumen and a second threaded portion surrounding the second lumen. Aklog et al (Figures 6B-6C) teaches wherein the external threads include a first threaded portion (604b) surrounding a first lumen (120) (Figure 6B) and a second threaded portion (604c) surrounding a second lumen (Figure 6C). 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 external threads, of the modified port of Aklog et al, to include a first threaded portion surrounding the first lumen and a second threaded portion surrounding the second lumen, as taught by Aklog et al (Figures 6B-6C), as such will lodge into the cortex layer, which allows the port to be screwed into place with an appropriate instrument (column 9, lines 4-6)(column 11, lines 55-58).
In regards to claim 8, Aklog et al (Figure 19) does not teach a graft extending between the first cavity and the second cavity. Aklog et al teaches another intraosseous port (Figure 21) comprising a graft (2008) extending between a first cavity and a second cavity (Figure 21). 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 port, of Aklog et al (Figure 19), with a graft extending between the first cavity and the second cavity, as taught by Aklog et al (Figure 21), as such will allow for the first cavity to communicate with the second cavity by creating a passageway therebetween (column 16, lines 15-21).
In regards to claim 9, in the modified port of Aklog et al, Aklog et al (Figure 19) does not teach wherein the graft is configured to extend between the bone and an under surface of a skin of the patient. Aklog et al (Figure 21) teaches wherein the graft is configured to extend between the bone and an under surface of a skin of the patient (Figure 21). 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 graft, of the modified port of Aklog et al, to be configured to extend between the bone and an under surface of a skin of the patient, as taught by Aklog et al (Figure 21), as such will allow for the first cavity to communicate with the second cavity by creating a passageway therebetween (column 16, lines 15-21).
Claims 11-12 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al, and further in view of Noble (WO 2013/003885).
In regards to claim 11, Aklog et al teaches a method of treating a patient, the method comprising;
coupling an intraosseous port (Figure 19) to a bone of the patient (Figure 19)
establishing a fluid connection between a medical system (1900) and the intraosseous port (Figure 19)
extracting a first bodily liquid (Figure 19), a first lumen (labeled in Figure 19 above) extending into a cavity (1816) (Figure 19)
delivering a second bodily liquid to the cavity via a second lumen (labeled in Figure 19 above) of the intraosseous port (Figure 19), the second lumen extending into the cavity (Figure 19)
wherein a distance between the first lumen and the second lumen is defined by a frame (1800/1804) of the intraosseous port (Figure 19)
Aklog et al does not teach extracting a first bodily liquid from a cavity of the bone via a first lumen of the intraosseous port, as Aklog et al instead teaches extracting a first bodily liquid from subcutaneous tissue via a first cavity (labeled in Figure 19 above) of the intraosseous port (Figure 19). Noble teaches a method comprising extracting a first bodily liquid from a cavity of a bone via a first lumen (610) of an intraosseous port (120) (paragraphs [0066][0082]). 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 extracting a first bodily liquid, of the method of Aklog et al, to be from a cavity of the bone via a first lumen of the intraosseous port, as taught by Noble, as such will allow for sampling the first bodily liquid from marrow of the bone for further analysis (paragraph [0066]).
In regards to claim 12, in the modified method of Aklog et al and Noble, Aklog et al teaches wherein the coupling the intraosseous port to the bone of the patient includes implanting the intraosseous port subcutaneously within the patient (Figure 19).
In regards to claim 14, in the modified method of Aklog et al and Noble, Aklog et al teaches wherein the extracting the first bodily liquid and the delivering the second bodily liquid occur simultaneously (Figure 19).
In regards to claim 15, in the modified method of Aklog et al and Noble, Aklog et al teaches wherein the second bodily liquid includes the first bodily liquid in a processed state in accordance with an operation of the medical system (Figure 19).
In regards to claim 16, in the modified method of Aklog et al and Noble, Aklog et al (Figure 19) does not teach wherein the coupling the intraosseous port to a bone of the patient includes threading the intraosseous port into the bone. Aklog et al teaches another method (Figures 6B-6C) wherein coupling an intraosseous port (Figures 6B-6C) to a bone of the patient includes threading the intraosseous port into the bone (Figures 6B-6C). 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 coupling the intraosseous port to a bone of the patient, of the modified method of Aklog et al (Figure 19) and Noble, to include threading the intraosseous port into the bone, as taught by Aklog et al (Figures 6B-6C), as such will lodge into the cortex layer, which allows the port to be screwed into place with an appropriate instrument (column 9, lines 4-6)(column 11, lines 55-58).
In regards to claim 17, in the modified method of Aklog et al and Noble, Aklog et al teaches wherein the establishing the fluid connection between the medical system and the intraosseous port includes:
piercing a first septum (labeled in Figure 19 above) of the intraosseous port with a first needle (Figure 19)
piercing a second septum (labeled in Figure 19 above) of the intraosseous port with a second needle (Figure 19)
In regards to claim 18, in the modified method of Aklog et al and Noble, Aklog et al (Figure 19) does not teach wherein: the intraosseous port includes a graft extending between the first lumen and the second lumen, and the establishing the fluid connection between the medical system and the intraosseous port includes: piercing the graft with a first needle, and piercing the graft with a second needle. Aklog et al teaches another method (Figure 21) wherein: an intraosseous port (Figure 21) includes a graft (2008) extending between a first lumen (inlet of 2000) and a second lumen (of 2006). 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 Aklog et al (Figure 19) and Noble, with the intraosseous port includes a graft extending between the first lumen and the second lumen, as taught by Aklog et al (Figure 21), as such will allow for the first cavity to communicate with the second cavity by creating a passageway therebetween (column 16, lines 15-21). However, neither Aklog et al (Figure 19) nor Aklog et al (Figure 21) teaches the establishing the fluid connection between the medical system and the intraosseous port includes: piercing the graft with a first needle, and piercing the graft with a second needle, as both Aklog et al (Figure 19) and Aklog et al (Figure 21) teach the establishing the fluid connection between the medical system and the intraosseous port includes: piercing a first septum (labeled in Figure 19 above, and similarly shown in Figure 21) with a first needle (Figures 19 and 21), and piercing a second septum (labeled in Figure 19 above, and similarly shown in Figure 21) with a second needle (Figures 19 and 21). But 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 establishing the fluid connection between the medical system and the intraosseous port, of the modified method of Aklog et al and Noble, to include piercing the graft with a first needle, and piercing the graft with a second needle, as either piercing a first septum with a first needle and piercing a second septum with a second needle, of Aklog et al (Figures 19 and 21), or piercing the graft with a first needle and piercing the graft with a second needle, of Applicant, will arrive at the same end result of accessing body liquid.
In regards to claim 19, in the modified method of Aklog et al and Noble, Aklog et al teaches wherein: the medical system is a hemodialysis system, and the treating the patient includes hemodialysis (column 14, lines 44-47).
In regards to claim 20, in the modified method of Aklog et al and Noble, Aklog et al teaches wherein extracting a first bodily liquid includes a flow rate of the first bodily liquid (Figure 19); however, Aklog et al is specifically silent about wherein extracting a first bodily liquid includes defining a flow rate of the first bodily liquid that exceeds about 50 ml/min. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify extracting a first bodily liquid includes a flow rate of the first bodily liquid, of the modified method of Aklog et al and Noble, to be extracting a first bodily liquid includes defining a flow rate of the first bodily liquid that exceeds about 50 ml/min, as Applicant has not disclosed that such a flow rate provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wherein extracting a first bodily liquid includes a flow rate of the first bodily liquid of an unknown flow rate, as taught by Aklog et al (Figure 19), as a person having ordinary skill in the art would have known how to select a flow rate for extracting a first bodily liquid for sufficient delivery of the first bodily liquid to be processed by a dialysis machine.
Response to Arguments
Applicant's arguments filed January 8, 2026, have been fully considered but they are not persuasive:
In regards to claims 1 and 11, Applicant argued: As Aklog discloses (i.e., shows in FIG. 19 and describes in col. 16, 11. 8-10) that the IOPs 1800, 1804 are separate devices (including separate frames), Aklog also discloses that the distance between first and second lumens (see Examiner's annotated FIG. 19 on page 7 of the Office Action) is defined by the placement locations of the separate IOPs 1800, 1804. Accordingly, Aklog does not disclose that the distance between first and second lumens is defined by the frames of the IOPs 1800, 1804. Consequently, Aklog fails to disclose "wherein the frame defines a fixed distance between the first lumen and the second lumen, " as required by claim 1. Accordingly, Aklog fails to disclose each and every element of claim 1, and therefore, Aklog fails to anticipate claim 1. Applicant has amended claim 11 similar to claim 1, and therefore, for the same reasons set forth above regarding claim 1, Aklog fails to anticipate claim 11 (Remarks, page 9). Examiner disagrees. Aklog et al teaches wherein the frame (1800/1804) defines a fixed distance between the first lumen (labeled in Figure 19 above) and the second lumen (labeled in Figure 19 above) (Figure 19).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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