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 .
Claim Objections
The claims contain minor informalities.
The amendments filed 11 February 2026 contain two claims numbered “10.” The second instance of claim 10 which describes “ctDNA” has been renumbered as claim 15.
Claim Rejections - 35 USC § 103
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 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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 2, 6-8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Locke; Christopher Brian et al. (US 20220370255 A1) as evidenced by Balasubramaniam; Swarna (US 20210068865 A1) in view of Roan; Esra et al. (US 20210052786 A1).
Regarding claim 1, Locke discloses a method for treating cancer (¶ [0002], [0003], [0004], [0006], a method for treating an infected breast implant; ¶ [0070], dressing 13 can be used to maintain symmetry between the patients breasts (e.g., after reconstructive breast surgery, breast cancer surgery, etc.));
the method comprising: obtaining surgical drain fluid from a surgical site of a tumor removal via a surgical drain (¶ [0038] Referring to FIG. 1, a dressing assembly 10 … vacuum tube 14; ¶ [0056], The exuded fluid is transferred through vacuum tube 14 to a canister, an exuded fluid container, etc.; ¶ [0061], FIGS. 10-13, dressing assembly 10 is shown, according to another embodiment … vacuum tube 14; ¶ [0065], FIG. 10 … Vacuum channel 22 is configured to fluidly couple vacuum tube 144 with negative pressure pathway layer 36);
evaluating one or more parameters of the drain fluid (¶ [0085] In some embodiments, therapy unit 100 includes a variety of sensors. For example, therapy unit 100 is shown to include a pressure sensor 130 configured to measure the pressure within canister 102 and/or the pressure at dressing 13 or cavity 68 or wound 114);
administering a treatment via the surgical drain (¶ [0035], The therapy unit can also include an instillation pump that is configured to deliver or drive the instillation fluid to the patient's breast cavity through the instillation tube and the instillation pathway layer; ¶ [0038] FIG. 1 … instillation tube 12; ¶ [0044], The therapy unit can be configured to draw a negative pressure at the cavity while also providing instillation fluid to the cavity; ¶ [0078], Instillation fluid 105 can include, for example, a cleansing fluid, a prescribed fluid, a medicated fluid, an antibiotic fluid, or any other type of fluid which can be delivered to wound 114 or cavity 68 during wound treatment); and
obtaining subsequent drain fluid samples via the surgical drain (¶ [0097] Process 2000 can also include reversing a direction of fluid removal/fluid delivery and repeating steps 2012-2014 (step 2016), according to some embodiments).
Locke does not explicitly obtain lymphatic fluid from a surgical site, and instead generally describes surgical drainage fluid (¶ [0044], A negative pressure can be drawn within the cavity … Negative pressure manifold 40 can also be configured to wick, absorb, or more generally, transfer fluid (e.g., wound exudate) from the cavity (e.g., from the breast cavity) … to vacuum channel 22). Locke is therefore silent whether the surgical drainage fluid contains lymphatic fluid.
Balasubramaniam discloses apparatuses and methods for improving post-operative recovery from bowel or other surgeries (¶ [0002], [0020], [0023], [0071], [0106] As shown in FIG. 2, one embodiment of the apparatus 100);
comprising obtaining fluid from a surgical site via a surgical drain (¶ [0109], a tube-like extension of silicone 107 … is connected to a vacuum source; ¶ [0124] FIG. 10A … The tubing 107 coupled to the apparatus 100, 100′ may be fluidly coupled to a pump 604 via an apparatus connection 602 and the tubing 107 may be used to remove the collected fluid during treatment);
wherein the fluid contains lymphatic fluid (¶ [0088], For example, in both minimally and maximally invasive surgeries, such as breast surgeries, hernia surgeries and surgeries in the arm pit region which are rich in lymph nodes and lymphatic fluids, it is desirable for the tissue flaps generated by surgery to seal to prevent seromas).
Balasubramaniam demonstrates that fluid removed from a breast surgery site contains lymphatic fluid, since the surrounding tissue comprises many lymph nodes (¶ [0088]). Locke collects surgical drain fluid from a breast surgery site (¶ [0044], Negative pressure manifold 40 can also be configured to wick, absorb, or more generally, transfer fluid (e.g., wound exudate) from the cavity (e.g., from the breast cavity); ¶ [0057], [0070], [0071], [0074], [0089]). Therefore, the fluid that Locke collects will necessarily contain lymphatic fluid.
Locke does not explicitly evaluate a cancer biomarker, administer a cancer treatment or evaluate efficacy of the treatment. Roan discloses a system and apparatus for the collection of serous or serosanguinous fluid from the percutaneous site after surgery (¶ [0009], [0084], [0087] FIG. 1 shows an exemplary embodiment of the present system);
a method for treating cancer (¶ [0014], Thus, the system(s) and method(s) disclosed herein permit significant versatility with a single worn vacuum device; ¶ [0142], either the upstream or downstream sample-collection apparatus, or the device, itself, may contain a reservoir of material 423 intended to be delivered to the patient for the purposes of pain-relief, treatment of disease (including any form of cancer));
the method comprising: obtaining surgical drain fluid from a surgical site of a tumor removal via a surgical drain (¶ [0087] FIG. 1 … A pump 6 creates a negative pressure in the connection 5 between the pump 6 and manifold 4 and imparts a negative pressure to the single or multiple drainage structures 3; ¶ [0091], FIG. 3 shows a perspective view of a combined pump, manifold, and disposable reservoir unit 14 placed on a bra 13 or mastectomy binder, which is commonly used following a mastectomy procedure; ¶ [0118] FIG. 14 shows a perspective view of the assembled pump unit device 87 and reservoir 88; ¶ [0120] FIGS. 16-23 yet another embodiment of the pump unit 120 and reservoir 140; ¶ [0156], FIG. 41 shows a similar representation as FIG. 39 with two separate peristaltic pumps 523, 523A, 524, 524A utilized for fluid removal);
evaluating one or more cancer biomarkers in the drain fluid (¶ [0143], Furthermore, the sample-collection apparatus may serve as the terminal vessel in which all further analysis of its contents (i.e. the sample) is carried out; ¶ [0150] A processing or analysis mechanism 458 may be used to further process or analyze the sample for characteristics including, but not limited to those elucidated by fluid cytology, and turbidity, the presence and characteristics of rare cells such as circulating tumor cells, proteins such as the carcinoembryonic antigen (CAE) and MUC-1, chemokines, growth factors and cytokines; ¶ [0151] FIG. 31 shows on embodiment of a dock … The dock may be used to further process or analyze the sample for characteristics);
administering a cancer treatment via the surgical drain (¶ [0142] In one embodiment of the device, either the upstream or downstream sample-collection apparatus, or the device, itself, may contain a reservoir of material 423 intended to be delivered to the patient for the purposes of pain-relief, treatment of disease (including any form of cancer) or infection, or any other medically-useful purpose); and
based on characteristics of the cancer biomarkers (¶ [0142], This material may be delivered at one or more time-points based on several factors which are either pre-programmed, determined by the device or sample-collection unit based on patient or sample parameters determined by onboard analysis, or delivered to the device via some communication protocol or feature).
Roan monitors a patient’s disease status and administers appropriate medications to treat the disease. One would be motivated to modify Locke with Roan’s cancer biomarker test, cancer treatment and evaluation since Locke calls for delivering a medicated fluid to a patient with cancer (¶ [0070], breast cancer surgery; ¶ [0078], a medicated fluid … during wound treatment). Therefore, it would have been obvious to modify Locke with Roan’s cancer biomarker test, cancer treatment and evaluation in order to monitor the patient’s condition and respond with appropriate medications.
Regarding claims 2 and 7, Locke does not explicitly evaluate cancer biomarkers. Roan discloses a method wherein the biomarkers are selected from tumor cells, cfDNA, and ctDNA (¶ [0150] A processing or analysis mechanism 458 … the presence and characteristics of rare cells such as circulating tumor cells);
wherein the biomarker is an antibody or antibody fragment (¶ [0150] A processing or analysis mechanism 458 … proteins such as the carcinoembryonic antigen (CAE) and MUC-1).
Roan monitors a patient’s disease status by testing for biological factors that correlate with cancer. Regarding the rationale and motivation to modify Locke with Roan’s cancer biomarker test, cancer biomarker test, see the discussion of claim 1 above.
Regarding claims 6 and 8, Locke obtains subsequent drain fluid samples within one hour, one day, or one week of administering the treatment (¶ [0076] FIG. 14 … Pneumatic pump 110 can be fluidly coupled with vacuum tube 14 and is configured to draw a negative pressure at cavity 68 through vacuum tube 14; ¶ [0080] Referring particularly to FIGS. 16-17 … pneumatic pump 110 can operate in the forward direction to pump air out of canister 102 and decrease the pressure within canister 102; ¶ [0086] Controller 118 can be configured to operate pneumatic pump 110, instillation pump 108, valve 132, and/or other controllable components of therapy unit 100. For example, controller 118 may instruct valve 132 to close and operate pneumatic pump 110 to establish negative pressure within the negative pressure circuit).
Locke appears to apply negative pressure during a repeating cycle and therefore obtains subsequent drain fluid samples during each iteration of the overall process (¶ [0089] Referring now to FIG. 20 … Process 2000 includes steps 2002-2016 and can be used to provide negative pressure wound therapy and instillation fluid to a breast cavity; ¶ [0097] Process 2000 can also include reversing a direction of fluid removal/fluid delivery and repeating steps 2012-2014 (step 2016)).
Locke is silent whether the surgical drainage fluid collected from a breast surgery site contains lymphatic fluid. Balasubramaniam demonstrates that fluid removed from a breast surgery site contains lymphatic fluid (¶ [0088]). Regarding the rationale that Locke’s collected fluid contains lymphatic fluid, see the discussion of claim 1 above.
Locke does not explicitly administer a cancer treatment and instead infuses a cleansing fluid, antibiotic fluid or medications in general (¶ [0078]). Roan discloses a method including evaluating the lymphatic fluid samples to evaluate efficacy of the treatment (¶ [0150] A processing or analysis mechanism 458 … the presence and characteristics of rare cells such as circulating tumor cells, proteins such as the carcinoembryonic antigen (CAE) and MUC-1; ¶ [0151] FIG. 31 shows on embodiment of a dock … The dock may be used to further process or analyze the sample for characteristics); and
administering a cancer treatment (¶ [0142], or the device, itself, may contain a reservoir of material 423 … treatment of disease (including any form of cancer)).
Regarding the rationale and motivation to modify Locke with Roan’s cancer treatment, see the discussion of claim 1 above.
Regarding claim 14, Locke discloses that fluid is obtained via a first port of the surgical drain (¶ [0038], Vacuum portion 16 includes a first channel, a first bore, a through-hole, a fluid passageway, a fluid path, an opening, an inner volume, an aperture, etc., shown as vacuum channel 22. … while vacuum channel 22 extends through vacuum portion 16 of connector 15); and
the cancer treatment is administered via a second port of the surgical drain (¶ [0038], Instillation portion 18 includes a second channel, a second bore, a through-hole, a fluid passageway, a fluid path, an opening, an inner volume, an aperture, etc., shown as instillation channel 20. Instillation channel 20 may extend through instillation portion 18 of connector 15).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Locke, Balasubramaniam and Roan in view of Savage; Jacqueline Sarah (US 20160199576 A1).
Regarding claim 3, Locke, Balasubramaniam and Roan lack a systemic chemotherapy agent. Savage discloses a method wherein the treatment is a systemic chemotherapeutic (¶ [0124] In addition to chemotherapy treatment delivery, described embodiments can be used for intravenous antibiotics administration; ¶ [0148] Described embodiments include the use of a new portable intravenous (IV) infusion system for the delivery of Chemotherapy treatment (and possibly other treatments); ¶ [0155] Microprocessor controlled pump mechanism for precise electronic delivery of chemotherapy drugs; ¶ [0190], FIGS. 1, 2A and 2B, a wearable system 100 for intravenous fluid delivery … The pump unit 140 acts as an infusion pump to deliver fluid from a fluid reservoir 130 to a delivery site 210 of a patient 102 via a fluid supply line 215).
Savage delivers a therapeutic agent according to a regimen that increases its efficacy against cancer (¶ [0126] The recent discovery of a new slow, low dose delivery method of chemotherapy has shown to not only alleviate physical side effects of the treatment but also increase the body's cellular response to the drugs; ¶ [0107] Recent research into a treatment method that involves continuous chemotherapy doses administered in small quantities has had very promising results … When low dose chemotherapy is administered on a daily schedule, the continual death of endothelial cells occurs, preventing or limiting new blood vessel formation and substantially disrupting the angiogenic process, slowing down tumour growth rapidly). One would be motivated to modify Locke and Roan with Savage’s systemic chemotherapy since Locke calls for delivering a medicated fluid to a patient with cancer (¶ [0070], [0078]). Therefore, it would have been obvious to modify Locke and Roan with Savage’s systemic chemotherapy in order to treat cancer with a known therapy.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Locke, Balasubramaniam and Roan in view of Konieczynski, David D. et al. (US 20030171738 A1) with incorporation of Laske; Douglas W. et al. (US 5720720 A).
Regarding claim 4, Locke, Balasubramaniam and Roan do not explicitly deliver a local chemotherapeutic agent. Konieczynski discloses a method wherein the treatment is a local chemotherapeutic (¶ [0005], This delivery mechanism, typically involving an implanted delivery catheter, is especially useful for targeting tumors, wherein a chemotherapeutic or other treatment agent is to be selectively applied to the tumor; ¶ [0024], This may be placed at a site such as a brain tumor or diseased region of the brain, at a tumor to deliver a chemotherapeutic agent, at an organ to deliver an organ-specific treatment, at a nerve location to treat chronic pain, or at another suitable local site).
Konieczynski simultaneously monitors and treats a tumor site, and selects specific medications to treat cancer. A skilled artisan would have been able to modify Locke and Roan with Konieczynski’s chemotherapy by incorporating Konieczynski’s chemotherapy as the therapeutic agent that Locke and Roan deliver to the patient. Therefore, it would have been obvious to modify Locke and Roan with Konieczynski’s local chemotherapy in order to treat cancer with a specific type of medication.
Regarding claim 5, Locke and Roan do not explicitly deliver an immunotherapy. Konieczynski incorporates Laske (¶ [0028], As such, the drug is delivered as a convection-enhanced, or pressure gradient-driven permeation of the target tissue, as described, for example, in U.S. Pat. No. 5,720,720; ¶ [0044], All patents and references disclosed above are expressly incorporated herein by reference in their entirety).
Laske discloses a method comprising an immunotherapy treatment (col. 2, lines 10-15, For example, in the case of tumor therapy, one may wish to expose much of the white matter in one hemisphere to antibody-conjugates in an attempt to destroy widely dispersed metastatic cells or fragments of tumor that project well beyond the main tumor mass).
Laske targets cancer cells which have drifted or fragmented away from a main tumor site. One would be motivated to modify Locke and Roan with Laske’s immunotherapy since Konieczynski calls for chemotherapeutic agents (¶ [0024], This may be placed at a site such as a brain tumor or diseased region of the brain, at a tumor to deliver a chemotherapeutic agent; ¶ [0034], The replaceable release cartridge may have a single active agent or may contain a "cocktail" of agents; ¶ [0039], Alternatively, the delivery agent may be another drug, adjuvant or the like). Therefore, it would have been obvious to modify Locke and Roan with Laske’s immunotherapy in order to target cancer cells with a specific anti-cancer agent.
Claims 9-12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Locke, Balasubramaniam and Roan in view of Myslinski; Lucas J. (US 20200077946 A1).
Regarding claims 9, 10, 12 and 15, Locke, Balasubramaniam and Roan do not detect biomarkers comprising cfDNA, ctDNA, methylated biomarkers or sequencing DNA. Myslinski discloses diagnostic systems and methods (¶ [0003], [0035], FIG. 1 … nano-nodes 100; ¶ [0049] The nano-node 100 and/or nano-routers 102 are able to be injected, implanted, ingested);
comprising evaluating one or more cancer biomarkers in a fluid, wherein the biomarkers comprise cfDNA or ctDNA (¶ [0048], Exemplary receptors are … RNA, DNA; ¶ [0087] In some embodiments, the nano-nodes 100 are able to detect biomarkers for specific cancers and/or circulating tumor DNA (ctDNA) for general cancer detection. For example, an abnormally high proportion of cfDNA from a specific tissue can indicate the possibility of a tumor in that tissue);
wherein the biomarkers are evaluated for methylation (¶ [0089] By detecting methyl-CpG, DNA methylation and/or cancer biomarkers, instead of injecting nano-nodes to a specific/target location, the nano-nodes are able to move and locate the cancer; ¶ [0090] Methylation patterns/signatures of tumor cells are altered compared to those of normal cells … Methyl-binding protein or antibodies that bind specifically to methylated-CpG residues are able to be used to interrogate the status of “DNA methyome” of diseased tissue in an efficient manner);
wherein evaluating one or more cancer biomarkers comprises sequencing DNA (¶ [0091] Pacific Biosciences has developed a real-time single molecule sequencing approach that is able to recognize methylated nucleotides from fluorescently labeled nucleotides present within a DNA strand);
Myslinski diagnoses cancer with commercially available tests or well-known proxies for cancer. One would be motivated to modify Locke, Balasubramaniam and Roan with Myslinski’s DNA-related biomarkers to more accurately detect cancer. Therefore, it would have been obvious to modify Locke, Balasubramaniam and Roan with Myslinski’s DNA-related biomarkers in order to diagnose cancer with a sensitive test.
Regarding claim 11, Locke, Balasubramaniam and Roan do not measure tumor cells or cfDNA. Myslinski measures a tumor cell concentration (¶ [0059], blood/tumor marker concentrations; ¶ [0085] FIG. 4 … Additional nano-nodes 100 are able to be utilized to monitor the situation for example, by detecting the number of cancer cells); and
cfDNA (¶ [0048], Exemplary receptors are … RNA, DNA; ¶ [0087] In some embodiments, the nano-nodes 100 are able to detect biomarkers for specific cancers and/or circulating tumor DNA (ctDNA) for general cancer detection. For example, an abnormally high proportion of cfDNA from a specific tissue can indicate the possibility of a tumor in that tissue).
Myslinski does not explicitly calculate a ratio of tumor cells to cfDNA in the lymphatic fluid. However, Myslinski measures both of these parameters and also uses them to diagnose cancer. Calculating a ratio of these indicators does not distinguish from Myslinski, since this ratio can be calculated or estimated mentally, by roughly dividing the two numbers, or perceiving the relative sizes of two plot lines on a graph. Regarding the rationale and motivation to modify Locke, Balasubramaniam and Roan with Myslinski’s various cancer biomarkers, see the discussion of claims 9, 10, 12 and 15 above.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Locke, Balasubramaniam and Roan in view of Hung, David et al. (US 20020002343 A1).
Regarding claim 13, Locke, Balasubramaniam and Roan do not disclose one of the specific claimed biomarkers. Hung discloses methods and systems for collecting breast duct fluid and diagnosing a cancer or precancer condition (¶ [0003], [0020], [0099], [0100]);
comprising evaluating one or more cancer biomarkers in a fluid, wherein the biomarkers comprise interleukin-1, interleukin-6, interleukin-10, a tumor necrosis factor, matrix metalloproteinase-1, matrix metalloproteinase-2, matrix metalloproteinase-9, or matrix metalloproteinase-13 (¶ [0069], the following cancer markers are listed here as exemplary … tumor necrosis factor (TNF); ¶ [0071], For example, the following markers can be identified to distinguish a cancer or precancer cell from a normal cell … Membrane Type 1 Matrix Metalloproteinase (MT 1-MMP), Matrix Metalloproteinase-3 (MMP-3)).
Hung identifies specific chemokines, growth factors or cytokines as relevant for diagnosing cancer. One would be motivated to modify Locke, Balasubramaniam and Roan with Hung’s TNF or MT 1-MMP detection to diagnose cancer since Roan calls for diagnosing cancer by testing for chemokines, growth factors and cytokines (¶ [0149] In one embodiment of the sample-collection unit, sensors 453 may be used to detect parameters including … chemokines, growth factors and cytokines, cellular debris including cytoplasmic fluid … or other markers for relevant disease states or conditions). Therefore, it would have been obvious to modify Locke, Balasubramaniam and Roan with Hung’s TNF or MT 1-MMP detection in order to detect cancer with specific biomarkers.
Response to Arguments
Applicant’s arguments filed 11 February 2026 regarding the rejection of claims 1-7 as amended, under 35 USC § 103 over Locke, Roan, Savage, Konieczynski and Laske, have been fully considered and are persuasive. After further consideration, the amended claims are rejected on new grounds under 35 USC § 103 over Locke, Balasubramaniam, Roan, Savage, Konieczynski, Laske, Myslinski and Hung (see above).
Applicant submits that both Locke and Roan fail to provide the claim element of evaluating lymphatic fluid (remarks p. 5). Applicant contends that Locke does not mention obtaining and/or evaluating lymphatic fluid. Similarly, Roan fails to disclose obtaining and/or evaluating lymphatic fluid (remarks p. 5).
Examiner responds that amended claim 1 is rejected over Locke, Balasubramaniam and Roan. Balasubramaniam demonstrates that surgical drain fluid contains lymphatic fluid (¶ [0088]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Alexander; Nelson et al. US 20200049599 A1
Myslinski; Lucas J. US 20200188708 A1
Imai; Kohzoh et al. US 20210208148 A1
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781