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 .
DETAILED ACTION
The examiner for this Application has changed. Please direct all future correspondence to Patent Examiner, Katriel B Kasayan, AU 1634. Additional contact information can be found at the end of this paper.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application is in response to papers filed on July 17, 2025. Pursuant to the amendments filed on July 17, 2025, claims 1-5, 7, 8, 14-17, 19-23, 25, 27-28, 38-42 are currently pending. Applicants’ election without traverse of Group III, e.g. claims 16-22 in response to restriction requirement filed on 12/28/2023 was previously acknowledged. Claims 1-5, 7, 8, 14-15, 23, 25, 27 and 28 were previously withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected invention, there being no allowable generic or linking claim.
Claims 6, 9-13, 18, 24, 26 and 29-37 are canceled. Claim 16 has been amended, and claims 41-42 are newly filed in Applicants’ amendment filed on July 17, 2025.
Therefore, claims 16, 17, 19-22, and 38-42 are currently under examination to which the following grounds of rejection are applicable.
Priority
The present application is a CON of International Application No. PCT/IN2020/05001 filed January 4, 2020, which claims priority to provisional application No. 62/814,075 filed March 5, 2019, and Indian Application No. 201911000546 filed January 4, 2019.
Thus, the earliest possible priority for the instant application is January 4, 2019.
Response to Arguments
Withdrawn Objections/Rejections in response to Applicants’ arguments or amendments:
Specification Objection
In view of Applicants’ amendments to the Specification filed July 17, 2025, wherein the term “AXTEX-4D” is marked in the Specification with the symbol ™ , the objection to the Specification is withdrawn.
Claim Rejections - 35 USC § 112
In view of Applicants’ arguments filed on July 17, 2025, the rejection of claims 16, 17, 19-22 and 38-40 under USC 112(a) as failing to comply with the enablement requirement has been withdrawn.
Claim 16 has been amended to recite the structure of the inoculation device comprising “ a non-woven polyethylene terephthalate (PET) fabric support base matrix system having a density of about 19 g/m to about 25 g/m, a thickness of about 0.05 mm to about 0.12 mm, a fiber thickness of about 0.5 dtex to about 10 dtex, and a porosity of about 20 micron to about 80 micron, for inoculation of less than 1000 cells. Therefore, the claims rejection under USC 112(a) has been withdrawn.
Applicants’ arguments are moot in view of the withdrawn rejections. A response to any argument pertaining to a new or maintained rejection can be found below.
Maintained Objections/Rejections in Response to Applicants’ arguments or amendments:
Claim Rejections - 35 USC § 103
Claims 16, 17, 20-22 and 38-40 remain rejected and claims 41-42 are newly rejected under 35 U.S.C.103 as being unpatentable over Yang et al. (US 2007/0099294A1) (ref. of record) in view of Mahapatra et al. (WO 2015/017626 A 1) (ref. of record).
This is a modified rejection necessitated by Applicants’ amendments to the claims in the response filed on July 17, 2025.
Regarding claim 16, Yang discloses methods and apparatuses for analyzing cellular function in three-dimensional culture [para 0006]. Yang also teaches the three-dimensional culturing of cells comprises a step of seeding cells on a sterilized cell support structure for three-dimensional cell culture in a device with at least one vessel for cell culture, having a bottom and at least one wall, where the device may have multiple vessels (plurality of chambers) that may be useful for allowing assays to be performed on more than one three-dimensional cell culture at one time [para 0051]. The cell support structure is a fibrous material, a porous material or both, and the fibers may be non - woven, such as polyethylene terephthalate (PET) [0048; claims 2 and 5]. Cell support structures may be cut with any suitable dimensions [0049;0051 ]. Moreover, Yang discloses performing cytotoxicity assays for drug screening and/or discovery using the device described above [0043]. In example 7, Yang discloses a microfluidic bioreactor array for carrying out perfusion 3D tissue culture in a high-throughput fashion, where the individual wells contain nonwoven PET fibrous matrices as the tissue engineering scaffold [0079; 0083]. Yang also teaches that the fiber density is 1.35g/cm2 [para 0049], a thickness of 1.0mm [para 0083], a fiber thickness of roughly 4 dtex (para [0049]; “fiber diameter. ~20 microns fiber density, 1.35 g/cm3”, and a porosity of roughly 45 micron (para [0083], “…resulting in matrices about 1.0mm thick with porosity of about 0.85 and average pore size of about 45 microns”). The Examiner notes that after calculating for fiber thickness, the corresponding conversion is roughly 4 dtex, absent to any evidence to the contrary.
However, Yang fails to disclose that the fiber density between 19 gm/m2 and 25 gm/m2, as recited in instant claim 16. Yang fails to teach inoculating less than about 1,000 cells (e.g, 500, 250, 100 or less than about 25 cells) from biopsied cells from a tumor from a patient.
In relation to the claimed structure of the non-woven polyethylene terephthalate (PET) fabric support base matrix system, it would have been obvious to optimize aspects of the non-woven PET fabric support base matrix device based on influential considerations in the design of the PET matrix, such as compression processing, heating the matrix, treatments etc. to achieve the fiber density between 19 gm/m2 and 25 gm/m2.
Mahapatra remedies Yang's deficiencies in relation to inoculating less than about 1,000 cells about from biopsied cells from a tumor from a patient. Mahapatra discloses methods for using a three-dimensional scaffold composition comprising randomly oriented fibers, wherein the fibers comprise a polyethylene glycol-polylactic acid block copolymer (PEG-PLA) and a poly(lactic-coglycolic acid) (PLGA) (3-P) (see abstract). Cancer cells cultured on the polymeric 3P scaffolds formed tight aggregates, termed tumoroids, similar to in vivo tumors (pg. 1, par. 3). Mahapatra further discusses that the 3-P scaffolds provide an excellent platform for producing tumoroids from tumor cell lines and from biopsies, and that the platform can be used to culture patient biopsies, test for anticancer compounds, and thereby allow the tailoring of a personalized cancer treatment (pg. 1 , par. 4). Furthermore, Mahapatra describes the polymeric 3D scaffolds as mimicking the physical interaction of the tumor with the topographical features of the native ECM (pg. 3, par. 2). In Example 9 of Mohapatra's disclosure, fine-needle aspirates (biopsies) of implanted mouse tumors were cultured and grown on the scaffolds in the presence or absence of two drugs (L Y294002 and U0126) to assess drug sensitivity of tumor biopsies (pg. 21, par. 2- 4).
Accordingly, it would have been obvious to a person of ordinary skill in the art to inoculate the plurality of chambers of a device as taught by Yang with biopsied cells from a tumor from a patient as taught by Mahapatra in the method of analysis of drug-sensitivity taught by Yang since primary cells obtained from patient biopsies have been cultured in the prior art in polymeric 3D scaffolds and exposed to drugs to analyze cell-drug sensitivity, as taught by Mahapatra. A person of skill in the art would have been motivated to use cells obtained from a biopsy performed on a patient since its use for culturing on a polymeric 3D scaffold for drug sensitivity assays have been disclosed before the effective filing date of the claimed invention, with the purpose of determining the chemosensitivity of cells in a potentially personalized approach.
Similarly, one or ordinary skill in the art would have been motivated to test different materials previously disclosed to be useful as support base matrix for three-dimensional growth of tissueoids, such as non-woven polyethylene terephthalate (PET) as taught by Yang, with the purpose of assessing if the material allows for in vivo-like culture as a 3-D scaffold that supports the cell population, its organization, and function. Moreover, a person of skill would have been able and motivated to combine Yang's and Mohapatra's disclosures by substituting the cancer cells disclosed by Yang with the primary cells obtained from patient biopsies to culture on nonwoven PET support base matrices, since a method for using and culturing primary cells on 3D polymeric scaffolds was disclosed by Mahapatra.
Regarding the number of cells in each sample of biopsied cells inoculated on the plurality of chambers, it would be obvious to those skilled in the art to determine the desired number of cells based on their experimental parameters or goals.
The instantly recited values would be within the realm of routine experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454,456, 1 05 USPQ 233,235 (CCPA 1955). See MPEP § 2144.05 part II A.
Since the claimed range is broad, encompassing from 1,000 to less than about 25 cells per inoculation, it would be obvious to determine all operable and optimal number of seeded cells because the number of seeded cells is an art-recognized, result-effective variable known to affect nutrient availability and cell viability, which would have been optimized in the art to provide the desired level of protection. It is noted that the limitation "generating three-dimensional tissueoids ... in less than 72 hours, wherein the tissueoids remain viable and retain functionality for at least 30 days" in instant claim 16 contains a wherein clause “wherein the tissueoids remain viable and retain functionality for at least about 30 days” that recites the intended result of the method rather than requiring an additional step be performed.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Regarding claim 17, Yang further discloses seeding cells of the human colon cancer cell line HT-29 into the PET matrices (providing samples for inoculating the plurality of chambers) to form the 3D tissue cultures (tissueoids) and studying the effects of different concentrations of 5-Fluorouracil (anti-cancer chemical agent- claim 20) on the cells' growth and viability [0082; 0085; 0088]. Yang compared the cell proliferation of eel Is exposed to the drug with the control, to which the drug was not added ([0088]; Fig. 21 ).
In addition, Yang discloses that an important component in a tissue-engineered construct that allows for in vivo-like culture is a 3-D scaffold that allows cell population support, organization, and function [0004]. Yang discloses that the cells can be cancer cells, colon cancer cells, and other types of cells [0042].
Regarding claim 20, the combined teachings of Yang and Mahapatra render obvious claim 16. Example 9 of Mohapatra's disclosure, fine-needle aspirates (biopsies) of implanted mouse tumors were cultured and grown on the scaffolds in the presence or absence of two drugs (L Y294002 and U0126) to assess drug sensitivity of tumor biopsies (pg. 21, par. 2- 4).
Moreover, it would have been obvious to use non-cancer tissue (LLC1 tumoroids, pp. 21) as a control for the drug as it was utilized in Mahapatra to compare the resistance of the drug on a biopsy-induced tumor and non-cancerous tumoroids. Additionally, it would be obvious to those skilled in the art compare a control tissue with cancerous tissue with the purpose of assessing if the drug or combination of drugs affect the subject’s normal tissue and/or if the effect is dose-dependent.
With respect to claims 21 and 22, Yang discloses a colon cancer model for drug screening in Example 6, which involves exposing colon cancer cells stably expressing EGFP (HT-29-GFP) to 3 chemicals: 5-FU, sodium butyrate, and gemcitabine in 2-D cultures, 3D low density cultures and 3-D tumor-like constructs [0077]. The cytotoxicity of the chemicals in 3D cultures was defined as a concentration range of the chemical, testing different doses and comparing to the control (without drug) [0077]. Yang also discloses a 3D cytotoxicity assay comprising seeding embryonic stem (ES) cells into PET scaffolds and exposing the cells to dexamethasone (OM) (anti-inflammatory), diphenylhydantoin (DPH), penicillin G (anti-bacterial), and 5-FU (anti-cancer) at various concentrations [0066; 0068]. In addition, Yang teaches that the method for analyzing cellular function of cells in three-dimensional culture comprises treating the culture with one or more test conditions, including one or a combination of introduction of conditions or agents that may have a therapeutic or toxic effect on the culture (claims 18 and 19). The controls contained the same cells without the drug [0066].
Regarding claim 38, the combined teachings of Yang and Mahapatra render obvious claim 16, It would be obvious to those skilled in the art to determine the desired number of cells based on their experimental parameters or goals.
Regarding claim 39 and 40, the combined teachings of Yang and Mohapatra render obvious claim 16. In relation to the recited “wherein clauses” of claim 39 and 40, they fail to recite active steps of the method and instead, provide no patentable weight, as the characteristics of the tissueoids are a direct result of the from the inoculations in less than 72 hours practiced the claimed method. MPEP 2111.04 states "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed" and that such a clause "'in a method claim is not given weight when it simply expresses the intended result of a process step positively recited." Therefore, since Yang in view of Mahapatra teaches the method steps as claimed, it is held that the results would be inherent to the method.
Regarding claim 41, the combined teachings of Mohapatra and Yang render obvious the claimed methodology of claim 16. Moreover, Yang teaches fiber thickness (para [0049]; “fiber diameter. ~20 microns fiber density, 1.35 g/cm3”). The Examiner notes that after calculating for fiber thickness, the corresponding conversion is roughly 4 dtex, absent to any evidence to the contrary.
Regarding claim 42 of claim 16, the combined teachings of Yang and Mohaptra render obvious the claimed methodology. Yang teaches the average pore size to be 45 microns (para [0083], “…resulting in matrices about 1.0mm thick with porosity of about 0.85 and average pore size of about 45 microns”).
Regarding claims 41 and 42, Yang does not explicitly teach that the fiber thickness is about 3.0 dtex, or that the porosity is about 65 micron.
It would have been obvious to optimize aspects of the non-woven PET fabric support base matrix device based on influential considerations in the design of the PET matric, such as compression processing, heating the matrix, treatments etc. to achieve a fiber thickness of 3.0 dtex or a porosity of about 65 micron.
The Court has stated that generally such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421.
MPEP § 2144 sets forth Applicant' s burden for rebuttal of a prima facie case of obviousness based upon routine optimization. Applicant must provide either a showing that the particular amount or range recited within the claims is critical; and/or a showing that the prior art reference teaches away from the claimed amount.
Claim 19 remains rejected under35 U.S.C.103 as being unpatentable over Yang et a/. (US 2007/0099294 A1) (ref. of record) in view of Mahapatra et al. (WO 2015/017626A1) (ref. of record) as applied to claim 16 above, in further view of Popolin et a/. (PLOS One, 2017) (ref. of record).
The teachings of Yang and Mahapatra can be found in the previous rejection above.
Yang in view of Mahapatra meet the limitations in claim 16. Regarding claim 19, neither Yang nor Mahapatra disclose using an additional control chamber containing a tissueoid comprising non-tumor normal cells from the patient.
However, Popolin investigated the effects of a series of biphosphine bipyridine Ru complexes (anti-cancer drugs) on different types of breast tumor cells and a non-tumor breast cell line (see abstract). Popolin exposed the cells to the complexes at different concentrations and compared the proliferation of the tumor cells and the non-tumor cells (pg. 10, par. 2 to pg. 11, par. 2). Popolin observed that one of the complexes inhibited the proliferation of the tumor cells more effectively compared to non-tumor cells and normal kidney cells, indicating that the complexes are specific to affect the viability of the tumor cells but not that of normal cells (pg. 11,par.2).
Accordingly, it would be obvious to those skilled in the art to include an additional control chamber comprising non-tumor normal cells from the patient with the purpose of assessing if the drug or combination of drugs affect the patient's normal cells and/or if the effect is dosedependent. One of ordinary skill would have been motivated to include an additional control chamber comprising non-tumor normal cells from the patient, as taught by Popolin, since it is important to determine if the drug or combination of drugs is selective to tumor cells or if the patient's normal cells will also be affected by the drugs' cytotoxicity, which would not be ideal when developing drugs to improve cancer treatment.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Response to Applicant Arguments as they apply to the rejection of claims 16, 17, 19-22 and 38-40 under 35 USC § 103
Beginning on page 9 of the remarks filed on July 17, 2025, Applicants’ essentially argue the following:
Yang does not teach or suggest such a method.
Yang does not disclose a method comprising providing a device having a plurality of sterile culture chambers for cell growth, each chamber containing a non-woven polyethylene terephthalate (PET) fabric support base matrix system having a density of about 19 gm/m2 to about 25 gm/m2, a thickness of about 0.05 mm to about 0.12 mm, a fiber thickness of about 0.5 dtex to about 10 dtex, and a porosity of about 20 micron to about 80 micron, as claimed in combination by Applicant.
Yang also does not disclose, for example, a method comprising inoculating the plurality of chambers of the device with the samples, each inoculation containing less than about 1,000 cells, as claimed in combination by Applicant.
Yang’s paragraph [0068] states:
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Thus, “Only a base matrix system such as that described and claimed by Applicant can support inoculations containing less than about 1,000 cells,”(Applicants’ remarks page 11, first para)
Mohapatra does not cure the above-described deficiencies of Yang. Mohapatra describes "a three-dimensional scaffold composition comprising randomly oriented fibers, wherein the fibers comprise a polyethylene glycol-polylactic acid block copolymer (PEG-PLA) and a poly(lactic-co-glycolic acid) (PLGA)" (Mohapatra Abstract). Mohapatra does not disclose a polyethylene terephthalate (PET) fabric support base matrix system in the first instance, much less one with the claimed combination of features. Mohapatra also does not teach the low seeding densities.
Popolin also does not cure the above-described deficiencies of Yang. Popolin does not even utilize 3D cell culture, but rather relies on traditional cell culture methods.
In response to the argument, it has been fully considered but is not persuasive due to the following reasons:
Regarding the first argument, Yang discloses a system and composition for an apparatus analyzing cellular function (e.g. light transmission, fluorometric, and/or calorimetric assays described in paragraph 0006), which are inherently used in a manner that involves steps of providing a plurality of sterile culture chambers [0051] and inoculating the plurality of chambers—comprising a PET based material—with the cells.
It is well established that an apparatus or composition disclosed in the prior art is sufficient to render a method of using such apparatus obvious. See In re Durden. In re Durden, 763 F.2d 1406, 226 USPQ 359 (Fed. Cir. 1985) (The examiner rejected a claim directed to a process in which patentable starting materials were reacted to form patentable end products. The prior art showed the same chemical reaction mechanism applied to other chemicals. The court held that the process claim was obvious over the prior art.).
Wherein clauses used in Applicants’ method of “generating tissuoids” are merely to describe the intended use of the disclosed system and would have been obvious as a matter of routine use of the composition.
Regarding the second and third argument, Applicants’ argue that Yang does not teach explicitly a non-woven polyethylene terephthalate (PET) fabric support base matrix system having a density of about 19 gm/m2 to about 25 gm/m2, a thickness of about 0.05 mm to about 0.12 mm, a fiber thickness of about 0.5 dtex to about 10 dtex, and a porosity of about 20 micron to about 80 micron. Moreover, Applicant discusses that Yang teaches that the scaffold has a density of 1.35g/cm3.
However, it would further be obvious with that the specific density, thickness and porosity are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration, diameter, density and porosity will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 2.
Regarding the third argument, Applicants’ argue that neither Mohapatra or Yang teach the inoculation of 1000 cells within the culture vessel, as required by the claims, however this argument is not persuasive.
Both Yang and Mohapatra teach systems wherein cells are provided to a scaffold or delivery construct to allow for cellular proliferation. The specific number of cells used, including whether 1000 or less cells can be used, constitutes a result-effective variable that would have been routinely optimized by one of ordinary skill in the art based on biological outcome. See § MPEP 2144.05, absent any evidence of unexpected results.
At the time of the claimed invention, specific number of proliferating cells and viability at low seeding densities are known to depend on multiple interacting factors, including but not limited to scaffolding properties, cell type, cell media, and/or growth factors present within the environment. Moreover, Baru et al. (Post-Filing Art. by Applicants Published Nov. 15 2020. bioRxiv 2020.11.05.369751) teaches that culture vessels comprising the AXTEX-4D™ platform (polymer platform used in the examples of the specification) were inoculated at 5000 cells per drop, which teaches the unpredictably associated with seeding into the claimed claimed non-woven polyethylene terephthalate (PET) fabric support base matrix (Baru et al. pp. 7 para 3, “Cell suspension was made in such a way that 1 ml of respective media contain 2.5 x 105 cells so that 20 µl of the media contained a cell number of 5000 cells per drop.”). Furthermore, paragraph 0035 of the Specification recites “Inocula in a range of cell numbers from 5000 cells and less were evaluated and the data shown here depict successful growth on the AXTEX-4D system of about 250 cells to as less as 25 cells”. Therefore, a person of skill in the art would have been motivated to optimize the number of cells to 5000 as the AXTEX-4D™ scaffold supports inoculations for up to 5000 cells. As such, determining an appropriate cell number—including values below 1000 cells—would have involved routine experimentation within the ordinary skill in the art, absent any evidence of unexpected results.
Regarding 4) Although it is noted that in paragraph [0086] of Yang’s disclosure that cells failed to proliferate at low densities within the matrix, they disclose that static batch culture did not support cell growth long term. However, Yang suggests that perfusion culture is more feasible for bioreactors with smaller volumes, and observed an increase in cell growth [0087]. Moreover, the instant claims do not require that the
Regarding the fifth argument, Mohapatra is used in combination with Yang for the teachings regarding the culture of cells obtained from biopsies. One cannot show obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 G2d 413,208 USPQ 871 (CCPA 1981); In re Merck & Co.¸ 800 F.2d 1091, 231 375 (Fed. Cir, 1986).
Moreover, the selection of a specific polymer (e.g. PEG-based polymers, PET based polymers), is a design choice known in the art to be interchangeable materials. Both PEG and PET were well known in the art as biocompatible polymers suitable for three-dimensional cell culture scaffolds. It is well established that a conclusion of obviousness is supported where the claimed invention differs from the prior art only by the substitution of one known element for another yielding predictable results. See KSR International Co. v. Teflex Inc.; MPEP § 2143.
Regarding the sixth argument, Popolin was relied upon to address the limitation of claim 19, which is drawn to the use of an additional control chamber comprising non-tumor normal cells from the patient. Popolin teaches the use of comparative cellular analysis, more specifically in evaluating the effect of anti-cancer drugs in cancer cells versus non-cancer cells. Moreover, Poplin’s use of a control group reflects standard experimental design principles that are routine in the art. Therefore, it would have been obvious to include a control chamber with normal cells with the motivation of comparative analysis of a drug.
New Grounds of Objection/ Rejection:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16, 17, 19-22, and 38-42 ejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. This is a new rejection necessitated by Applicants’ amendments to the claims in the response filed July 17, 2025.
Regarding claim 16, it is indefinite in the recitation of the phrase “a fiber thickness of about 0.5 dtex to about 10 dtex”. It is unclear whether the fiber thickness refer to fibers present in the non-woven fabric matrix of polyethylene terephthalate or to additional fibers. As such the metes and bounds of the claim are indefinite. It is noted that the post-filing art of Baru et al. (Post-Filing Art. Published Nov. 15 2020. bioRxiv 2020.11.05.369751) mentions that the fabric, which is comprised of fibers, has a density but not explicitly the fabric support matrix system. Moreover, the post-filing art recites that “the thickness of the fibers is 0.05-5mm” but not the thickness of the support matrix system (pp. 7 para 1).
Claims 17, 19-22, and 38-42 are rejected insofar as they depend on claim 16.
Claim objection
Claim 16 is objected to because abbreviations such as gm/m2, mm, and dtex should be spell out should be spelled out at the first encounter in the claims. Appropriate correction is required.
Conclusion
No claims are allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Katriel B Kasayan whose telephone number is (571)272-1402. The examiner can normally be reached 10-4p.
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/KATRIEL BARCELLANO KASAYAN/ Examiner, Art Unit 1634
/MARIA G LEAVITT/ Supervisory Patent Examiner, Art Unit 1634