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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01 June 2026 has been entered.
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, 16 and 17 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 Fantl; Wendy J. et al. (US 20090269773 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. Fantl discloses a method for determining the status of an individual (¶ [0003], [0027], detecting the minimal residual status of a disease in an individual; ¶ [0070], [0071]);
the method comprising: obtaining lymphatic fluid (¶ [0083] Generally, the most easily obtained samples are fluid samples … urine, lymphatic fluid, amniotic fluid; ¶ [0085], In some embodiments, the sample is a lymph node sample …combinations of one or more of a blood, bone marrow, cerebrospinal fluid, and lymph node sample are used; ¶ [0274], cells isolated from peripheral blood and those from bone marrow or lymph nodes; ¶ [0321] Samples may be blood samples, lymph node samples, other appropriate samples (dependent on the solid tumor type), or a combination of sample types);
evaluating one or more cancer biomarkers in the fluid indicative of minimal residual disease (¶ [0050] FIG. 1 … Here, the cell number is increasing and by the sixth measurement has exceeded the threshold number; ¶ [0280] In some embodiments, the analysis obtained in step 1501 may be used to determine the best therapy for an individual, which may include the determination that the best therapy for a patient is supportive care; ¶ [0283], the existence of minimal residual disease after treatment may be when the ratio of the number of cells exhibiting a cancerous state to total cells in a sample, e.g., a blood sample, exceeds a certain percentage, such as 0.0001%, 0.001%, 0.01%, or 0.1%); and
administering a cancer treatment via the surgical drain based on characteristics of the cancer biomarkers (¶ [0027], The minimal residual status refers to the number of disease-associated cells that remain in the individual during treatment or after treatment when the individual is in remission. In some embodiments, the minimal residual status of a disease in an individual is used to determine a health status in the individual; ¶ [0033], determining an appropriate course of treatment for said individual based on said status of the individual … stopping, shortening, prolonging, or modifying an existing therapy, adding an additional therapy to existing therapy, or combinations of the foregoing; ¶ [0064] FIG. 15 … The method can be applied to an individual before a diagnosis, an individual undergoing a treatment, or an individual undergoing remission or having a relapse; ¶ [0076], Such information allows for ongoing monitoring of the condition and/or additional treatment; ¶ [0327] In one embodiment, the appropriate therapy is the administration of a chemical agent that is a chemotherapy agent used to treat malignancies; ¶ [0328] Also included in the definition of "chemotherapeutic agent" are anti-hormonal agents).
Fantl directs a patient’s therapy based on the patient’s response to therapy and trends in their health status (¶ [0081], Samples may be obtained once or multiple times from an individual …e.g., a series of samples taken to monitor response to treatment or to monitor for return of a pathological condition; ¶ [0280], the analysis obtained in step 1501 may be used to determine the best therapy for an individual; ¶ [0285], the ratio between particular predefined classes of cells can be analyzed to see if the ratio is trending in a particular direction, just as for absolute numbers. FIG. 3 illustrates such an analysis).
A skilled artisan would have been able to modify Locke with Fantl’s cancer cell analysis by extracting a lymphatic fluid sample, computing a ratio of cancerous to normal cells in the sample and then comparing the ratio to a threshold (Fantl ¶ [0283]). One would be motivated to modify Locke with Fantl’s cancer biomarker evaluation in order to detect a relapse and optionally to administer further therapy. Therefore, it would have been obvious to modify Locke with Fantl’s cancer biomarker evaluation in order to detect a relapse earlier and then decide which therapy to administer.
Regarding claims 2 and 7, Locke does not explicitly evaluate cancer biomarkers. Fantl discloses a method wherein the biomarkers are selected from tumor cells, cfDNA, and ctDNA (¶ [0283], the existence of minimal residual disease after treatment may be when the ratio of the number of cells exhibiting a cancerous state to total cells in a sample, e.g., a blood sample, exceeds a certain percentage, such as 0.0001%, 0.001%, 0.01%, or 0.1%);
wherein the biomarker is an antibody or antibody fragment (¶ [0123] The term "antibody" includes full length antibodies and antibody fragments; ¶ [0133] In some embodiments, an epitope-recognizing fragment of an activation state antibody rather than the whole antibody is used).
Fantl monitors a patient’s disease status by testing for biological factors that correlate with cancer. Regarding the rationale and motivation to modify Locke with Fantl’s cancer biomarker test, see the discussion of claim 1 above.
Regarding claims 6, 8, 16 and 17, Locke obtains subsequent 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 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]). Fantl discloses a method comprising obtaining subsequent lymphatic fluid samples (¶ [0087], Monitoring can be performed weekly, bi-weekly, monthly … or any combination thereof; ¶ [0321] Samples may be blood samples, lymph node samples … or a combination of sample types);
further comprising assessing efficacy of a cancer treatment by evaluating the one or more cancer biomarkers in the subsequent lymphatic fluid samples (¶ [0278] FIG. 15 … the method of the present invention can be applied to an individual before a diagnosis, an individual undergoing a treatment, or an individual in remission or having a relapse as depicted in step 1500 of FIG. 15. In step 1501, cells from the individual are analyzed according to the method described herein; ¶ [0327] In one embodiment, the appropriate therapy is the administration of a chemical agent that is a chemotherapy agent used to treat malignancies; ¶ [0328] Also included in the definition of "chemotherapeutic agent" are anti-hormonal agents);
wherein obtaining subsequent lymphatic fluid samples is performed within one hour, one day, or one week of administering the cancer treatment (¶ [0082], the samples may be obtained at fixed intervals … or some combination thereof … at intervals of approximately 1, 2, 3, or 4 weeks);
further comprising adjusting the cancer treatment based on the assessed efficacy (¶ [0280] In step 1502 of FIG. 15, a diagnosis, prognosis, method of treatment or response to treatment is determined after the analysis in step 1501. Thus the analysis of step 1501 allows for the diagnosis, prognosis, choice or modification of treatment … In some embodiments, the analysis obtained in step 1501 may be used to determine the best therapy for an individual).
Regarding the rationale and motivation to modify Locke with Fantl’s biomarker test and 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 Fantl in view of Savage; Jacqueline Sarah (US 20160199576 A1).
Regarding claim 3, Locke, Balasubramaniam and Fantl do not explicitly disclose 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 Fantl with Savage’s systemic chemotherapy since Locke calls for delivering a medicated fluid to a patient with cancer (¶ [0070], [0078]). Fantl also lists multiple chemotherapy agents that are commonly administered systemically (¶ [0327]). Therefore, it would have been obvious to modify Locke and Fantl 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 Fantl 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 Fantl 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 Fantl with Konieczynski’s chemotherapy by incorporating Konieczynski’s chemotherapy as the therapeutic agent that Locke and Fantl deliver to the patient. Therefore, it would have been obvious to modify Locke with Konieczynski’s local chemotherapy in order to treat cancer with a specific type of medication.
Regarding claim 5, Locke and Fantl 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 Fantl 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). Also, Fantl calls for delivering anti-hormonal agents as a cancer therapy (¶ [0328] Also included in the definition of "chemotherapeutic agent" are anti-hormonal agents). Therefore, it would have been obvious to modify Locke and Fantl 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 Fantl in view of Myslinski; Lucas J. (US 20200077946 A1).
Regarding claims 9, 10, 12 and 15, Locke, Balasubramaniam and Fantl 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 and Fantl with Myslinski’s DNA-related biomarkers to more accurately detect cancer. Therefore, it would have been obvious to modify Locke and Fantl with Myslinski’s DNA-related biomarkers in order to diagnose cancer with a sensitive test.
Regarding claim 11, Locke and Balasubramaniam do not measure tumor cells or cfDNA. Fantl discloses a method that measures a tumor cell concentration and a ratio of tumor cells to total cells (¶ [0013], [0030], [0283], the existence of minimal residual disease after treatment may be when the ratio of the number of cells exhibiting a cancerous state to total cells in a sample, e.g., a blood sample, exceeds a certain percentage, such as 0.0001%, 0.001%, 0.01%, or 0.1%). Regarding the rationale and motivation to modify Locke with Fantl’s cancer biomarker evaluation, see the discussion of claim 1 above.
Locke, Balasubramaniam and Fantl do not measure 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. For example, Fantl explains how to count a number of cells in a sample, then to calculate various ratios of cell categories as a diagnostic marker (¶ [0011], [0013], [0015], [0030], [0032], [0261]). Regarding the rationale and motivation to modify Locke, Balasubramaniam and Fantl 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 Fantl in view of Hung, David et al. (US 20020002343 A1).
Regarding claim 13, Locke, Balasubramaniam and Fantl 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 and Fantl with Hung’s TNF or MT 1-MMP detection to diagnose cancer since Fantl calls for diagnosing cancer by testing for various chemokines, antibodies and cytokines (¶ [0123] The term "antibody" includes full length antibodies and antibody fragments; ¶ [0124], interleukin 2 receptor; ¶ [0130], Examples of proteins that can be analyzed with the methods described herein include … cathepsins, metalloproteinases, esterases, hydrolases). Therefore, it would have been obvious to modify Locke and Fantl with Hung’s TNF or MT 1-MMP detection in order to detect cancer with specific biomarkers.
Response to Arguments
The objections to claims 10 and 15 for improper numbering are withdrawn in view of the amendments filed 01 June 2026.
Applicant’s arguments filed 01 June 2026 regarding the rejection of claims 1-15 as amended, under 35 USC § 103 over Locke, Balasubramaniam, Roan, Savage, Konieczynski, Laske, Myslinski and Hung, 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, Fantl, Savage, Konieczynski, Laske, Myslinski and Hung (see above).
Applicant’s arguments regarding Roan have been considered but are moot because the reference is no longer cited in the current rejection.
Applicant submits that Roan is focused on a device and is simply missing the elements of the claims noted above (remarks p. 5). Applicant reasons that none of the cited art report evaluation of one or more cancer biomarkers in the fluid to determine whether residual cancer is present at a surgical site or determination of an appropriate therapy based on the biomarkers (remarks p. 5). Examiner notes that Roan is not cited in the new grounds of rejection. Locke, Balasubramaniam and Fantl are cited in the new grounds of rejection as teaching all features of amended claim 1.
Fantl explicitly discloses a method that obtains a lymphatic fluid sample (¶ [0083], lymphatic fluid; ¶ [0085], a lymph node sample; ¶ [0274], cells isolated from … lymph nodes; ¶ [0321], lymph node samples), evaluates the sample (¶ [0050], [0280], [0283]) and then adjusts the patient’s treatment based on biomarkers found in the sample (¶ [0033], [0064], [0076], [0327], [0328]).
Applicant asserts that claim 1 requires "administering a cancer treatment via the surgical drain based on characteristics of the cancer biomarkers" (remarks p. 6). Examiner responds that Fantl adjusts a patient’s treatment based on characteristics of cancer biomarkers (¶ [0033], [0064], [0076], [0327], [0328]).
Applicant reasons that this requires a closed-loop integration: cancer biomarkers are evaluated, and the results of that evaluation drive administration of a cancer treatment through the same drain. No reference, alone or in combination, teaches this integration (remarks p. 6). Examiner acknowledges that the specification and drawings describe a system where fluid is removed through a first port and therapeutic agents are delivered through a second port, and wherein the ports are fluidically connected (¶ [0020] As shown in FIG. 2, in certain aspects, the proximal portion 104 of the drain tube and the proximal portion 115 of the treatment tube are fluidically connected 203). However, the claims do not call for closed-loop integration and instead call for “… lymphatic fluid … via a surgical drain … and administering a cancer treatment via the surgical drain …” The term “surgical drain” is broad enough to cover Locke’s bidirectional fluid passages (¶ [0038], instillation tube 12 and vacuum tube 14. Connector 15 includes … vacuum portion 16, and … instillation portion 18).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., closed-loop integration, i.e. exchanging fluids in two directions through a single lumen by periodically reversing their direction) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant contends that this rationale mischaracterizes Locke's disclosure. At [0070], Locke does not report delivering medicated fluid to a patient with cancer. It describes using the dressing to maintain breast symmetry after surgery, "e.g., after reconstructive breast surgery, breast cancer surgery, etc." This is context for why an implant might be present in a patient, not a teaching of cancer treatment. The Examiner's characterization conflates a wound care scenario with an oncology treatment method (remarks p. 6). Examiner acknowledges that Locke does not disclose any anti-cancer agents. Fantl is are cited in the new grounds as teaching a chemotherapy agent (¶ [0327], [0328]).
Applicant submits that Roan collects post-surgical fluid for general characterization (remarks p. 7). Examiner responds that Roan is no longer cited in the current rejection. Locke, Balasubramaniam and Fantl are cited in the new grounds of rejection as teaching all features of amended claim 1.
Applicant asserts that with respect to claim 11 … The issue is not whether a person could mathematically divide two values, but whether the prior art teaches or suggests that the ratio of tumor cells to cfDNA in lymphatic fluid is a meaningful cancer biomarker. None of the cited references recognizes this ratio as clinically relevant or diagnostically useful. Myslinski reports measuring tumor cell concentration and detecting cfDNA independently. But it does not teach combining these quantities into a ratio, nor does it suggest that such a ratio would provide (remarks p. 7). Examiner responds that claim 11 is rejected on new grounds over Locke, Balasubramaniam, Fantl and Myslinski. Fantl describes how to calculate a ratio of cell counts as a diagnostic marker.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Weiskopf; Kipp Andrew et al. US 20160069898 A1
Pruteanu-Malinici; Iulian et al. US 20210396739 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights