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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/17/26 has been entered.
Response to Amendment
The amendment filed 04/17/26 has been entered. Claims 1 and 3-5 have been amended. Claim 2 is in the original/ previously presented form. Thus, claims 1-5 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Final Office Action mailed 11/17/25.
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 (i.e., changing from AIA to pre-AIA ) 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, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Cully, Jr. (U.S. PGPUB No. 2024/0050725), hereinafter Cully, in view of De La Fuente Gonzalez et al. (U.S. PGPUB No. 2017/0246258), hereinafter Gonzalez, and Sanyal (U.S. PGPUB No. 2015/0065379).
Regarding claim 1, Cully discloses an enclosure system for removal of undesired cells from a human body (see [0045-0046]: system retains biological moieties such as cells and see [0047]: a hydrogel can be used within the pouch to retain the cells), comprising:
an enclosure body (102, see FIG. 1) that is elastic and expandable (see [0049]: a pouch, aligning with Applicant’s disclosure of the elasticity/ expansion being due to the pouch in [0019]), formed with a cavity (108, see FIG. 2 and [0049]: a reservoir) and a closable opening (see [0049]: periphery of pouch bag 110 is sealed except for port 107, where lumen 112 extends into pouch, see FIG. 2. See [0049]: lumen does not need to be held “open” and is therefore closable) and includes at least a first port and a second port (see [0066-0067]: multiple ports, such as a first port and a second port, fluidly connected to reservoir and accessible from outside the body may be used. Thus, Cully discloses a first and second port);
wherein, the body (102) is constructed for placement in a desired location of the human body (see [0012]: i.e.: implanted in a tissue pocket), and capable of (capable of is functional language. Therefore, the device only need be capable of “receiving” the following recited components through the first and second ports) receiving a first set of chemicals through the first port, an injection of normal saline through the first port, and a second set of chemicals through the second port (see [0066-0068]: ports can introduce cells/ chemicals as described and therefore the body “is capable of” receiving sets of chemicals and/or normal saline through the first port and the second port);
and
wherein the body (102) is constructed to enclose the cells that move into the cavity (see [0066]: body encloses cells 136 introduced into cavity and see [0050]: cells can also move into cell permeable layer 116 seen in FIG. 6), to be configured to close after a preselected time period (see [0049]: lumen is closed such that the sides of the lumen touch, see [0070], until removal as in [0073-0074]) and, thereafter, to be configured for removal from the human body (see [0073-0074]).
Cully is silent to removing cells “that contains a tumor formed of the undesired cells,” placing the enclosure body “near the tumor”, wherein the second set of chemicals “includes a preselected chemoattractant that is operable to direct the undesired cancer cells, including the tumor, toward them”, “wherein the first set of chemicals includes DNase I;”, and “wherein the body is constructed to enclose the tumor and associated cancer cells that move into the cavity because of the chemoattractant,” to be closed after a preselected time period and, thereafter, to be removed from the human body.
However, Gonzalez teaches an enclosure system (see [0021-0024]: for example, a 2D/3D scaffold with a chemoattractant to serve as a capture agent and chemoattractant for tumor cells and [0057-0059]: scaffold provided within a medical device to trap tumor cells with chemoattractant and [0060]: form is a scaffold or hydrogel) for removal (see [0051], [0067], [0073], [0084]: the device is implanted and then removed) of undesired cells from a human body that contains a tumor formed of the undesired cells (see [0021-0024]: the agent of the invention encourages metastatic tumor cells to attach to surface/ be contained by device), comprising:
an enclosure body (see [0057]: i.e.: a medical device containing the scaffold/ hydrogel body);
wherein, the body is constructed for placement in a desired location of the human body near the tumor (see [0053]: implant body implanted within area of human body dependent on cancer type. For example, ovarian cancer would have implant in abdominal wall),
wherein the body (see [0021-0024] and [0057]: medical device containing the scaffold) includes a preselected chemoattractant that is operable to direct the undesired cancer cells, including the tumor, toward them (see [0021-0023], [0057-0059]: medical device with scaffold includes chemoattractant for directing tumor cells into device); and
wherein the body (see [0021-0024] and [0057]: medical device containing the scaffold) is constructed to enclose the tumor and associated cancer cells that move into a cavity because of the chemoattractant (see [0021-0023], [0057-0059]: medical device with scaffold includes chemoattractant for directing tumor cells into cavity of device, where scaffold is located), to be in use for a preselected time period (see [0036-0039]: device used for certain number of hours, days, weeks) and, thereafter, to be removed from the human body (see [0051], [0067], [0073], [0084]: the device is implanted and then removed).
First, therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical device pouch with hydrogel layers disclosed in Cully to include the scaffold/ hydrogel including chemoattractant as taught by Gonzalez for the purpose of forming an implantable device that traps metastatic cancer cells and is therefore useful for the treatment of cancer (see [0057]), thus achieving removing cells “that contains a tumor formed of the undesired cells,” and “wherein the body is constructed to enclose the tumor and associated cancer cells that move into the cavity because of the chemoattractant,” to be closed after a preselected time period and, thereafter, to be removed from the human body.
Next, therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second set of chemicals introduced through the port disclosed in Cully to include a chemoattractant as taught by Gonzalez for the purpose of encouraging tumor cells to become trapped in the device (see [0021-0023], [0057-0059]) and refreshing the chemoattract concentration such that the chemoattract gradient does not become “gradually lost” over time (see [0219]), which could allow the device to remain implanted within the patient for a longer duration, thus achieving wherein the second set of chemicals “includes a preselected chemoattractant that is operable to direct the undesired cancer cells, including the tumor, toward them”
Lastly, therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implantable pouch device disclosed in Cully to be implanted such that the placing of the enclosure body is near the tumor as taught by Gonzalez for the purpose of implanting the device near the site of treatment (see [0055]: i.e.: implant in the abdominal cavity for ovarian cancer) and to facilitate further cell capture based on biological processes (see [0053-0055]: for example implanting in peritoneal cavity/ abdomen is facilitated by trascoelomic flow), thus achieving placing the enclosure body “near the tumor.
Cully in view of Gonzalez remain silent to “wherein the first set of chemicals includes DNase I”.
However, Sanyal teaches an enclosure system (see FIG. 2) for removal of undesired cells from a human body (see [0021]) comprising an enclosure body (210) that is elastic and expandable (see [0023-0028]: pouches) and comprises a first set of chemicals, wherein the first set of chemicals includes DNase I (see [0021] & [0058]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the first set of chemicals provided through the first port disclosed in Cully to be DNase as taught by Sanyal for the purpose of facilitating release and collection of the cervix, endocervical, and uterine cells (see [0021]), thus achieving “wherein the first set of chemicals includes DNase I”.
Regarding claim 2, the modified system of Cully teaches the system of claim 1, and Cully further discloses wherein the body (102, see FIG. 1) is formed as a pouch bag (see [0049]: a pouch 102).
Regarding claim 3, the modified system of Cully teaches the system of claim 1, but Cully is silent to “further wherein the first set of chemicals includes collagenase I.”
However, Sanyal teaches an enclosure system (see FIG. 2) for removal of undesired cells from a human body (see [0021]) comprising an enclosure body (210) that is elastic and expandable (see [0023-0028]: pouches) and comprises a first set of chemicals, wherein the first set of chemicals includes collagenase I (see [0021] & [0058]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the first set of chemicals provided through the first port disclosed in Cully to be collagenase as taught by Sanyal for the purpose of facilitating release and collection of the cervix, endocervical, and uterine cells (see [0021]), thus achieving “further wherein the first set of chemicals includes collagenase I.”
Regarding claim 5, the modified system of Cully teaches the system of claim 1, but Cully is silent to “wherein the chemoattractant is defined using expression data of plasma membrane protein receptors obtained by RNA seq NGS.”
However, Sanyal teaches analyzing a biological material to determine a personalized treatment protocol for a subject (see [0043-0044]) using expression data of plasma membrane protein receptors obtained by RNA seq NGS (see [0040-0044] & [0067-0075]. See [0067] for specifically “next generation” sequencing).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chemoattract taught by Modified Cully to be defined using expression data of plasma membrane protein receptors obtained by RNA seq NGS as taught by Sanyal for the purpose of providing a personalized therapy and treatment protocol for a subject based on the subject’s data (see [0043-0044]), thus achieving “wherein the chemoattractant is defined using expression data of plasma membrane protein receptors obtained by RNA seq NGS.”
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Cully in view of Gonzalez and Sanyal as applied to claim 1 above, and further in view of Condeelis et al. (U.S. PGPUB No. 2012/0322685), hereinafter Condeelis.
Regarding claim 4, the modified system of Cully teaches the system of claim 1, but Modified Cully is silent to “further wherein the chemoattractant includes lysophosphatidic acid (LPA).”
However, Condeelis teaches an enclosure system for removal of cells from a human body (see FIGURE 2 and [0009-0011]), the enclosure system (see FIGURE 2) including a chemoattractant (see [0013]), further wherein the chemoattractant includes lysophosphatidic acid (LPA) (see TABLE 1 on page 8 between [0057] and [0058]. See [0057]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the chemoattractant of Cully in view of Gonzalez to include LPA as taught by Condeelis for the purpose of stimulating cell migration into the device (see TABLE 1 of Condeelis), thus achieving “further wherein the chemoattractant includes lysophosphatidic acid (LPA).”
Response to Arguments
Applicant's arguments filed 04/17/26 have been fully considered but they are not persuasive.
On pages 4-5, Applicant argues that the combination of references fail to teach “an injection of normal saline through the first port” and therefore the 35 U.S.C. § 103 claim rejections of claim 1 and the depending claims should be withdrawn. The examiner disagrees because the breadth of the claims is not as argued by Applicant. Claim 1 lines 5-8 read “wherein, the body is constructed for placement in a desired location of the human body … and capable of receiving a first set of chemicals through the first port, an injection of normal saline through the first port, and a second set of chemicals through the second port”. Therefore, the examiner maintains that the primary reference, Cully, discloses the first port “capable of” receiving an injection of normal saline because Cully discloses the ports receiving different compositions via the fluidly coupled ports. Thus, the ports function to receive any kind of fluid, such as “normal saline” therethrough (see rejection of claim 1 above for further explanation). Thus, in response to applicant's argument that normal saline must be flushed through the first port of the device, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Cully’s ports receive fluids and are therefore capable of receiving any fluid such as normal saline. Therefore the examiner was not persuaded by this argument and maintains the 35 U.S.C. § 103 claim rejections.
Next, on page 5, Applicant argues that one of the secondary references, Sanyal, teaches away from introducing “normal” saline because Sanyal describes introducing a “physiological” saline. However, the examiner disagrees with this argument. Sanyal may teach using a “physiological” saline as a “preferable” embodiment, but Sanyal does not specifically discredit/ criticize/ otherwise discourage the use of “normal” saline. Therefore, the examiner is not persuaded that Sanyal truly teaches away from a delivery of “normal” saline” (See MPEP § 2141.02.VI and 2143.01.I: "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed". see also MPEP § 2123.II: Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).) Therefore, the examiner was not persuaded by this argument and maintained the 35 U.S.C. § 103 claim rejections.
Lastly, Applicant asserts that the current Application has criticality for a separate injection of “normal” saline for washing the enzymes. However, this argument is not persuasive because the breadth of the claims are not as argued by Applicant. Claim 1 does not require that a “separate injection of normal saline” be performed “for washing” enzymes. 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., a separate injection of normal saline introduced through the first port to wash the enzymes) 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). Therefore, the examiner is not persuaded by this argument in view of the currently recited claim language and has maintained the 35 U.S.C. § 103 claim rejections.
Because no further arguments were presented, the examiner maintained the 35 U.S.C. § 103 claim rejections of the depending claims as well.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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