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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 8, 2026, has been entered.
Acknowledgments
In the reply, filed on July 8, 2026, Applicant amended claims 1, 3, 11, 16, and 20.
In the final rejection of April 22, 2026, Examiner noted that the information disclosure statement filed April 7, 2023 (37 pages), fails to comply with 37 CFR 1.98(a)(2). Applicant submitted a copy of Written Opinion for PCT/US2021/035232. Concern is withdrawn.
Examiner objected to claims 1, 11, 16, and 20. Applicant amended claims 1, 11, 16, and 20. Objection is withdrawn.
Examiner rejected claims 1-12 and 14-20 under 35 U.S.C. 112(a). Applicant amended claims 1 and 11, and argued support for claim 3 (Remarks, page 7). Rejection is withdrawn.
Examiner rejected claim 20 under 35 U.S.C. 112(b). Applicant amended claim 20. Rejection is withdrawn.
Claim Objections
Claim 11 is objected to because of the following informalities:
In regards to claim 11, line 9, “a first lumen” should be changed to “the first lumen”.
In regards to claim 11, line 11, “a second lumen” should be changed to “the second lumen”.
In regards to claim 11, line 12, “the cavity,” should be changed to “the cavity”.
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 position of the first lumen relative to 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 11, lines 6-7 recite: “the frame defining a fixed position of the second lumen relative to the first lumen”; 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.
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, 10-12, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Noble (WO 2013/003885).
In regards to claim 1, Noble teaches an intraosseous port (Figure 6), comprising:
a rigid frame (120) configured for subcutaneous placement within a patient, the frame comprising:
a proximal portion (400) having a first cavity (portion of 230 in 400) and a second cavity (portion of 610 in 400), the first cavity and the second cavity configured for fluidly coupling with a medical system
a distal portion (210) configured for insertion through a bone wall, the distal portion including:
a first lumen (portion of 230 in 210) extending along the distal portion between the first cavity and a first open distal end of the first lumen
a second lumen (portion of 610 in 210) extending along the distal portion between the second cavity and a second open distal end of the second lumen, wherein the first open distal end and the second open distal end are configured for placement within a cavity of a bone
wherein the frame defines a fixed position of the first lumen relative to the second lumen (Figure 6)
an anchoring mechanism (220) configured for securing the frame to the bone
In regards to claim 2, Noble teaches wherein the anchoring mechanism includes external threads (220).
In regards to claim 3, Noble teaches wherein the second open distal end is spaced longitudinally along the cavity of the bone away from the first open distal end (Figure 6).
In regards to claim 4, Noble teaches wherein the second cavity is disposed laterally with respect to the first cavity (Figure 6).
In regards to claim 5, Noble teaches wherein the second lumen is disposed laterally with respect to the first lumen (Figure 6).
In regards to claim 6, Noble teaches wherein the external threads include a first threaded portion (portion of 220 surrounding 230) surrounding the first lumen and a second threaded portion (portion of 220 surrounding 610) surrounding the second lumen.
In regards to claim 10, Noble teaches wherein the bone wall includes a humerus (paragraph [0003]); however, Noble does not specifically teach 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 which 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. Noble 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 Noble, is capable of being inserted through the bone wall including the greater tubercle of the humerus, as claimed.
In regards to claim 11, Noble teaches a method of treating a patient, the method comprising:
coupling an intraosseous port (Figure 6) to a bone of the patient (paragraph [0003]), the intraosseous port comprising a rigid frame (120) including:
a first lumen (230) having a first open distal end
a second lumen (610) having a second open distal end
the frame defining a fixed position of the second lumen relative to the first lumen (Figure 6)
establishing a fluid connection between a medical system and the intraosseous port (paragraphs [0070][0082])
extracting a first bodily liquid from a cavity of the bone via a first lumen (230) of the intraosseous port, the first lumen extending into the cavity (paragraph [0070]: fluids or gasses can travel through the lumen 230… from the marrow 110)
delivering a second bodily liquid to the cavity via a second lumen (610) of the intraosseous port, the second lumen extending into the cavity (paragraph [0082]: there is a tube 620 attached to the additional lumen 610, which can be used to deliver… various liquids or gasses)
In regards to claim 12, Noble teaches wherein the coupling the intraosseous port to the bone of the patient includes implanting the intraosseous port subcutaneously within the patient (Figure 1)(paragraphs [0003][0084]).
In regards to claim 14, Noble teaches wherein the extracting the first bodily liquid and the delivering the second bodily liquid occur simultaneously (Figure 6)(paragraphs [0070][0082]).
In regards to claim 16, Noble teaches wherein the coupling the intraosseous port to the bone of the patient includes threading the intraosseous port into the bone (paragraphs [0065][0074]).
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 7-9, 15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Noble, as applied to claims 1 and 11 above, and further in view of Aklog et al (US 10,426,940).
In regards to claim 7, Noble is silent about a first septum extending across a proximal opening of the first cavity; and a second septum extending across a proximal opening of the second cavity, wherein the first septum and the second septum are configured for passage of a needle therethrough. Aklog et al teaches an intraosseous port (Figures 22-23) comprising a first septum extending across a proximal opening of a first cavity (of 2200); and a second septum extending across a proximal opening of the second cavity (of 2202), wherein the first septum and the second septum are configured for passage of a needle therethrough (Figure 23). 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 Noble, with a first septum and a second septum, as taught by Aklog et al, as such will prevent reflux of fluids into the subcutaneous tissue (column 5, lines 14-17).
In regards to claim 8, Noble is silent about a graft extending between the first cavity and the second cavity. Aklog et al teaches an 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 Noble, with a graft, as taught by Aklog et al, 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 Noble and Aklog et al, Noble is silent about wherein the graft is configured to extend between the bone and an under surface of a skin of the patient. Aklog et al teaches wherein the graft is configured to extend between a bone and an under surface of a skin of a 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 Noble and 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, 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 15, Noble is silent about wherein the second bodily liquid includes the first bodily liquid in a processed state in accordance with an operation of the medical system. Aklog et al teaches a method of treating a patient (Figure 21), wherein a second bodily liquid includes a first bodily liquid in a processed state in accordance with an operation of a medical system (2100) (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 second bodily liquid, of the method of Noble, to include the first bodily liquid in a processed state in accordance with an operation of the medical system, as taught by Aklog et al, as such will allow for treating patients with renal disease by hemodialysis (column 14, lines 13-22).
In regards to claim 17, Noble is silent about wherein the establishing the fluid connection between the medical system and the intraosseous port includes: piercing a first septum of the intraosseous port with a first needle, and piercing a second septum of the intraosseous port with a second needle. Aklog et al teaches a method of treating a patient (Figures 22-23), wherein establishing a fluid connection between a medical system (2300) and an intraosseous port (2200/2202) includes: piercing a first septum of the intraosseous port with a first needle, and piercing a second septum of the intraosseous port with a second needle (2304) (Figure 23). 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 method of Noble, to include piercing a first septum of the intraosseous port with a first needle, and piercing a second septum of the intraosseous port with a second needle, as taught by Aklog et al, as the septums, through which needles may pass to access the port, will prevent reflux of fluids into the subcutaneous tissue (column 5, lines 14-17).
In regards to claim 18, Noble is silent about 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 a method of treating a patient (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 method, of Noble, with the intraosseous port includes a graft extending between the first lumen and the second lumen, as taught by Aklog et al, 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, Aklog et al does not teach establishing a fluid connection between a medical system and the intraosseous port includes: piercing the graft with a first needle, and piercing the graft with a second needle, as Aklog et al instead teaches establishing a fluid connection between a medical system (2100) and the intraosseous port includes: piercing a first septum with a first needle (Figure 21), and piercing a second septum with a second needle (2102) (Figure 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 Noble and Aklog et al, 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, 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 providing access to body liquid, thus being obvious alternatives.
In regards to claim 19, Noble is silent about wherein: the medical system is a hemodialysis system, and the treating the patient includes hemodialysis. Aklog et al teaches a method of treating a patient, wherein: a medical system is a hemodialysis system, and the treating the patient includes hemodialysis (column 14, lines 44-47). 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 Noble, with the medical system is a hemodialysis system, and the treating the patient includes hemodialysis, as taught by Aklog et al, as such will allow for treating patients with renal disease (column 14, lines 13-22).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Noble, as applied to claim 11 above.
In regards to claim 20, Noble is silent about wherein the extracting the first bodily liquid includes defining a flow rate of the first bodily liquid that exceeds 50 ml/min. However, Noble does teach wherein the delivering the second bodily liquid includes defining a flow rate of the second bodily liquid of about 200 ml/min (paragraphs [00117][00118])), thus supporting that the intraosseous port, of Noble, can handle flow rates of about 200 ml/min, which exceeds 50 ml/min. Therefore, 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 the extracting the first bodily liquid, of the method of Noble, to include defining a flow rate of the first bodily liquid that exceeds 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 the delivery flow rate of the second bodily liquid of about 200 ml/min, of Noble, supporting that the intraosseous port can handle a similar extraction flow rate of the first bodily liquid, as a person having ordinary skill in the art would have known how to select a flow rate for extracting the first bodily liquid to achieve sufficient samples of the first bodily liquid for further analysis.
Response to Arguments
Applicant’s arguments with respect to claims 1-12 and 14-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In regards to claim 18, Applicant argued: Regarding claim 18, the Examiner has alleged that it would have been obvious to modify the method to include piercing the graft with first and second needles because "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." (See Office Action, page 13.) Applicant submits that this rationale is conclusory and unsupported. Aklog teaches septum-based access, not graft piercing. The Examiner has not identified any teaching, suggestion, or motivation in the prior art that would lead one of ordinary skill in the art to pierce a graft instead of using the established septum-based access taught by Aklog. The mere assertion that both methods could theoretically provide fluid access does not establish obviousness without some rationale for why one would choose to pierce a graft rather than a septum (Remarks, pages 10-11). Examiner disagrees. Either piercing a first septum with a first needle and piercing a second septum with a second needle, of Aklog et al, 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 providing access to body liquid, thus being obvious alternatives.
In regards to claim 20, Applicant argued: Regarding claim 20, the Examiner has alleged that it would have been "an obvious matter of design choice" to modify the method such that extracting a first bodily liquid includes defining a flow rate exceeding 50 ml/min. (See Office Action, page 14.) However, the Examiner has not cited any prior art evidence that teaches or suggests a flow rate of 50 ml/min or higher in the context of intraosseous fluid extraction. A "design choice" argument requires some showing that the claimed parameter was within a range known in the art. Here, the Examiner has provided no evidence from Aklog, Noble, or any other reference that teaches or suggests flow rates in this range for intraosseous fluid extraction. Accordingly, the Examiner's rejection of claim 20 is improper (Remarks, page 11). Examiner disagrees. While Noble is silent about wherein the extracting the first bodily liquid includes defining a flow rate of the first bodily liquid that exceeds 50 ml/min, Noble does teach wherein the delivering the second bodily liquid includes defining a flow rate of the second bodily liquid of about 200 ml/min (paragraphs [00117][00118])), thus supporting that the intraosseous port, of Noble, can handle flow rates of about 200 ml/min, which exceeds 50 ml/min. Therefore, 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 the extracting the first bodily liquid, of the method of Noble, to include defining a flow rate of the first bodily liquid that exceeds 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 the delivery flow rate of the second bodily liquid of about 200 ml/min, of Noble, supporting that the intraosseous port can handle a similar extraction flow rate of the first bodily liquid, as a person having ordinary skill in the art would have known how to select a flow rate for extracting the first bodily liquid to achieve sufficient samples of the first bodily liquid for further analysis.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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