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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/28/2026 has been entered.
Status of Claims
Claims 1, 3-5, and 7-9 are pending and examined on the merits. Claims 10-12 are withdrawn from consideration.
Status of Prior Rejections
The rejection of claim 1 is under 35 U.S.C. 112(b) is withdrawn in light of the amendment to the claim 1 to read “(2) placing the primary tumor cell obtained from step (1) in a hollow fiber, which is then implanted into an animal
The rejection of claims 1, 3, 5, and 7-9 under 35 U.S.C. 103 over Hollingshead (US 5,698,413), in view of Freshney (Culture of Animal Cells, 2010, Chapter 24) and Sun (CN103898056) is withdrawn in light of the amendment to claim 1 to require Non-Essential Amino Acids Solution and Non-Essential Amino Acids Solution in the composition of (1).
The rejection of claims Claims 1 and 4 under 35 U.S.C. 103 over Hollingshead (US 5,698,413), in view of Freshney (Culture of Animal Cells, 2010, Chapter 24), Sun (CN103898056), Roife (Surgery, 2017, 161(5): 1246-1254), Cajulis (Diagnostic Cytopathology, 1993, 9(1): 43-45), and Roy-Chowdhuri (Modern Pathology, 2017, 30: 499-508) is withdrawn in light of the amendment to claim 1 to require Non-Essential Amino Acids Solution and Non-Essential Amino Acids Solution in the composition of (1).
Claims 1 remains rejected under 35 U.S.C. 103 as over Hollingshead (US 5,698,413), in view of Freshney (Culture of Animal Cells, 2010, Chapter 24), Sun (CN103898056), Takahashi (J Oral Maxillofac Surg, 2014, 72(9): e168) and Cluntun (Trends Cancer, 2017, 3(3): 169-180, Author manuscript). Applicant’s arguments are addressed following the rejection.
The cancellation of claim 2 renders any rejections thereof moot.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-5, and 7-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for obtaining an animal model for screening anti-tumor drugs as recited in claim 1, wherein the animal is an immunodeficient mouse, does not reasonably provide enablement for the method of claim 1, wherein the animal is not an immunodeficient mouse. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to carry out the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01(a)). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
The nature of the invention: The nature of the invention is a method for obtaining an animal model for screening anti-tumor drugs, comprising: (1) cultivating a primary tumor cell obtained from a tumor sample of a patient in a composition as recited in claim 1, wherein the primary tumor cell is cultivated with a mouse embryonic fibroblast (MEF) cell treated with mitomycin C; and wherein the patient is a human patient having a tumor, and the animal model is used for screening anti-tumor drugs for the specific human patient having the specific tumor; and (2) placing the primary tumor cell obtained from step (1) in a hollow fiber, which is then implanted into an animal.
The breadth of the claims: Claims 1, 3-5, and 7-9 encompass a method for obtaining an animal model for screening anti-tumor drugs, wherein the animal is any animal, including an immunocompetent mouse, a salamander, and a platypus. Claims 5 and 9 limits the animal to a mouse, a rat, or an immunodeficient mouse.
The state of the prior and post-filing art:
Morton (Caner Research, 2017, 76(21): 6153-6158) teaches that humanized mouse xenograft models allow researchers to examine xenograft growth in the context of a human immune system and resultant tumor microenvironment (Abstract). Morton teaches that xenograft models utilize humanized mice, which are highly immunodeficient mouse strains into which human immune systems can be engrafted (Abstract).
Goto (Journal of Personalized Medicine, 2020, 10(3): 64) teaches that the xenograft model, which has been often used as an in vivo model for cancer research, involves the implantation of cultured tumor cell lines established from tumor tissue into immunodeficient mice (p 2, para 2). Goto teaches that immunodeficient mice are indispensable for a PDX model; human tumors will initiate a graft versus host reaction, leading to rejection in immune-competent mice (p 3, para 2).
Liu (Signal Transduction and Targeted Therapy, 2023, 8: 160) teaches that patient-derived xenograft (PDX) models, in which tumor tissues from patients are implanted into immunocompromised or humanized mice, are an ideal choice in cancer treatment studies, such as preclinical trials of novel drugs, validating novel drug combinations, screening drug-sensitive patients, and exploring drug resistance mechanisms (Abstract). Liu teaches that to avoid tumor engraftment rejection in mouse models, conventional PDX models are typically created using immunocompromised mice, such as athymic nude mice, severe combined immunodeficiency (SCID) mice, non-obese diabetic-severe combined immunodeficiency (NOD-SCID) mice, NOD-SCID-/IL2λ-receptor null (NSG) mice, BALB/cRag2 null/ IL2λ-receptor null (BRG) mice and Rag-2 null/Jak3 null (BRJ) mice (p 3, col 2, para 3). Liu teaches that different mouse strains have various degrees of immunosuppression, and they are thus endowed with different engraftment rates, which are higher in more immunocompromised mice (BRG/BRJ > NSG > NOD/SCID > SCID > nude) (p 3, col 2, para 3).
The level of one of ordinary skill: One of ordinary skill in the art is a research scientist holding a postgraduate degree or equivalent experience.
The level of predictability in the art:
The prior and post-filing art, as set forth above, teaches that the use of immunocompromised mice is essential for that patient-derived xenograft (PDX) models. Goto teaches that Goto teaches that human tumors will initiate a graft versus host reaction, leading to rejection in immune-competent mice (p 3, para 2). Liu teaches that to avoid tumor engraftment rejection in mouse models, conventional PDX models are typically created using immunocompromised mice, and that that different mouse strains have various degrees of immunosuppression, and they are thus endowed with different engraftment rates, which are higher in more immunocompromised mice (p 3, col 2, para 3). The prior art does not teach patient-derived xenograft (PDX) models using immune-competent mice, or an animal model using a species other than mice. Therefore, there was a high level of unpredictability regarding a method for obtaining an animal model for screening anti-tumor drugs, wherein the animal is any animal, as encompassed by claims 1, 3-4, and 7-8, and wherein the animal is an immunocompetent mouse or rat, as encompassed by claims 5 and 9.
Working examples and the amount of guidance:
The instant specification recites that in embodiments, the animal in the present invention is a mouse or a rat, in particular an immunodeficient mouse, such as a nude mouse (p 3, line 29 – p 4, line 8; p 8, line 22 – p 9, line 2). The specification does not provide guidance on other types of animals that could be used in the method of the instant claims.
Furthermore, the working examples of the animal model in the specification employ female Balb/c Nude mice (p 13, Section 1.2; p 19, Section 5.2). There are no working examples wherein an immunocompetent mouse is used, as encompassed by claims 5 and 9, or wherein a non-murine model is used, as encompassed by claims 1, 3-4, and 7-8.
The quantity of experimentation necessary:
Based on the content of the disclosure and the state of the prior art, undue experimentation is required to carry out the invention as claimed. As discussed above, the experimental examples disclosed in the specification are limited to embodiments of the invention wherein immunocompromised mice are used as the animal model. The prior and post-filing art, as set forth above, teaches that the use of immunocompromised mice is essential for that patient-derived xenograft (PDX) models to avoid tumor engraftment rejection. Neither the specification nor the prior art provides guidance on using immunocompetent mice, or a non-murine animal species, in PDX models. Given the unpredictability of using an animal other than an immunodeficient mouse in PDX models, additional experimentation is required to carry out the method of the instant claims using an animal other than an immunodeficient mouse. Therefore, in light of the breadth of the claims, the limited guidance in the specification with respect to the breadth, and the state of the art, undue experimentation is required to carry out the invention as broadly claimed.
In conclusion, the evidence provided in the disclosure, in light of the teachings available in the art, does not enable one skilled in the art to make the claimed invention without undue or reasonable experimentation. Therefore, the method recited in claim 1 is not enabled in its full breadth. Claims 3-5 and 7-9 are included in the rejection because they depend directly or indirectly from claim 1. Claims 5 and 9 are included in the rejection because although they recite the limitation “wherein the animal is a mouse, a rat, or an immunodeficient mouse,” the limitation of an immunodeficient mouse is listed in the alternative.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 5, and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Hollingshead (US 5,698,413), in view of Freshney (Culture of Animal Cells, 2010, Chapter 24), Sun (CN103898056), Takahashi (J Oral Maxillofac Surg, 2014, 72(9): e168) and Cluntun (Trends Cancer, 2017, 3(3): 169-180, Author manuscript).
Sun is in the Chinese language. Citations are made to the WIPO machine translation provided in the Office Action mailed 03/25/2025.
Hollingshead teaches a method of screening chemotherapeutic agents in vivo (Abstract). The method comprising cultivating target cells in vitro, encapsulating said target cells in a hollow fiber tubing, implanting the hollowing fiber tubing into a laboratory animal, then treating said animal with a test chemotherapeutic agent (col 3, ln 35-57).
Hollingshead teaches that the target cells may be human tumor xenografts, or fresh patient-derived tumor tissue (col 4, ln 13) (claim 1). Target cells are cultivated in vitro in an appropriate culture medium, which may be Dulbecco's modified MEM (DMEM), and includes 10% fetal calf serum (reads on 10% fetal bovine serum) for most cell lines (col 4, ln 19-25) (claim 1). The hollow fiber may be made of polyvinylidene fluoride (PVDF) having a molecular weight cutoff value of 500,000 Dalton (col 4, ln 40-42 and 50-54; col 8, Example 2) (claim 7). The hollow fibers are implanted subcutaneously into the recipient animal (claim 8), which may be a mouse or rat (claims 5, 9) (col 4, ln 18-49; col 8, Example 2). After implantation, the laboratory animals are treated with the test chemotherapeutic agent on a dose and schedule appropriate for the agent being evaluated. The implanted samples are then harvested at the appropriate time for in vitro evaluation of the effects of the chemotherapeutic agent (col 7, ln 1-17) (claim 9).
Hollingshead does not teach 1) cultivating the primary tumor cells with a mitomycin C-treated mouse embryonic fibroblast (MEF), 2) cultivating primary tumor cells obtained from a biopsy sample, or 3) the composition recited in step (1) of claim 1, aside from DMEM and FBS.
Freshney teaches the use of feeder layers for the culture of primary tumor cells, to aid the growth of tumor cells (p 464, col 1, para 3; p 466-467, Section 24.5.2). Freshney teaches a protocol, wherein tumor cells obtained from a biopsy (claim 3) are grown on MEFs treated with Mitomycin C (p 466-467, Protocol 24.2).
Regarding difference 1: It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hollingshead by culturing primary tumor cells on mitomycin C-treated MEFs, as taught by Freshney. One of ordinary skill in the art would have been motivated to make this modification because Freshney teaches that the use of a feeder layer aids the growth of tumor cells. One of ordinary skill in the art would have had a reasonable expectation of successfully making this modification because Freshney teaches that the use of feeder layers has been applied successfully to many types of tumors (p 466, Section 24.5.2, para 1).
Regarding difference 2: It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hollingshead, in view of Freshney, by using tumor tissue from a biopsy, as taught in Freshney. One of ordinary skill in the art would have been motivated to make this modification because Freshney teaches that tissue from a biopsy provides valuable material (p 464, Section 24.2.2). One of ordinary skill in the art would have had a reasonable expectation of successfully making this modification because Hollingshead teaches that fresh patient-derived tumor tissue can be used in the method taught therein (col 4, ln 13), and Freshney teaches that primary tumor cells obtained from a biopsy can be cultivated on MEF feeder cells (p 466, Section 24.5.2, para 1).
Regarding difference 3: The medium taught in Hollingshead comprises 10% FBS or 20% FBS (col 4, ln 19-25; col 7, ln 45) (claim 1(1)(h)). Hollingshead, in view of Freshney, does not teach a composition comprising the components (a)-(g) and (i)-(j) of claim 1.
Sun teaches an “improved F culture medium” (also referred to as “modified F culture medium,” e.g., Table 1) for culturing primary human tumor cells (p 1, Summary of the Disclosure), wherein the medium comprises:
0.2-0.5 μg/ml [0.2-0.5 mg/L] of hydrocortisone (reads on 0.4 mg/L Hydrocortisone);
3-6 μg/ml [3-6 mg/L] of insulin (reads on 5 mg/L Insulin);
6-10 ng/ml [6-10 μg/L] of cholera toxin B (reads on 8.3 μg/L Cholera toxin);
22-25 μg/ml [22-25 mg/L] of adenine (reads on 24.2 mg/L Adenine);
9-12 ng/ml [9-12 μg/L] of human EGF (reads on 10 μg/L EGF);
7-9 μmol/L of Y-27632;
100 U ml of penicillin and 100 μg/ml of streptomycin (reads on Pen/Strep);
Ham's F-12 medium (reads on F12 medium); and
DMEM High Glucose (reads on DMEM with high glucose).
Sun teaches that culturing primary tumor cells in the improved F culture medium results in faster growth of cells, compared to culturing in a standard F culture medium (p 1, “Background” and “Summary of the Disclosure”; p 4, Table 6).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hollingshead, in view of Freshney, by incorporating the F culture medium of Sun to culture primary tumor cells. One of ordinary skill in the art would have been motivated to make this modification because the method of Hollingshead, in view of Freshney, comprises culturing human primary tumor cells, and Sun teaches that the use of the improved F culture medium results in improved growth of human primary tumor cells. One of ordinary skill in the art would have had a reasonable expectation of successfully making this modification because Sun teaches that the -improved F culture medium can used to culture human primary tumor cells.
Regarding the concentration of Y-27632 in the composition: Sun teaches a concentration of 7-9 μmol/L of Y-27632. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the concentration of Y-27632 on factors such as the type of primary tumor cells or the duration of culture, to arrive at the claimed invention. Routine optimization is not considered inventive and no evidence has been presented that increasing the concentration of Y-27632 in the composition from 7-9 μmol/L, as taught by Sun, to 10 μmol/L as claimed, was other than routine, that the composition resulting from the optimization have any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. As noted in In re Aller, 105 USPQ 233 at 235, where 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. See MPEP 2144.05(II)(A).
Hollingshead, in view of Freshney and Sun, does not teach a composition comprising Non-Essential Amino Acids Solution or L-alanyl-L-glutamine dipeptide.
Takahashi teaches extracting tumor tissue from the lymph node of a human patient, then culturing the primary tumor cells in a growth medium comprising DMEM, MEM-NEAA (MEM Non-Essential Amino Acids Solution), and GlutaMAX (reads on L-alanyl-L-glutamine dipeptide) (col 1, para 2).
Cluntun teaches that cancer cells depend on an exogenous supply of Non-Essential Amino Acids, including glutamine (p 1, para 1 – p 2, para 2).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hollingshead, in view of Freshney and Sun, by adding Non-Essential Amino Acids Solution and L-alanyl-L-glutamine dipeptide to the culture medium, as taught in Takahashi. One of ordinary skill in the art would have been motivated to make this modification because Cluntun teaches that cancer cells depend on an exogenous supply of Non-Essential Amino Acids, including glutamine (p 1, para 1 – p 2, para 2). One of ordinary skill in the art would have had a reasonable expectation of successfully making this modification because Takahashi teaches that a medium comprising Non-Essential Amino Acids and L-alanyl-L-glutamine dipeptide can be used to culture human primary tumor cells obtained from a biopsy.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Hollingshead (US 5,698,413), in view of Freshney (Culture of Animal Cells, 2010, Chapter 24), Sun (CN103898056), Takahashi (J Oral Maxillofac Surg, 2014, 72(9): e168), Cluntun (Trends Cancer, 2017, 3(3): 169-180, Author manuscript), and Roife (Surgery, 2017, 161(5): 1246-1254), as evidenced by Cajulis (Diagnostic Cytopathology, 1993, 9(1): 43-45) and Roy-Chowdhuri (Modern Pathology, 2017, 30: 499-508).
The teachings of Hollingshead, Freshney, Sun, Takahashi, and Clutun, are set forth above. Hollingshead, in view of Freshney, Sun, Takahashi, and Clutun, renders obvious claim 1.
Regarding claim 4: Hollingshead, in view of Freshney, Sun, Takahashi, and Clutun, does not teach the method of claim 1, wherein the tumor sample is obtained from a needle biopsy sample.
Roife teaches the use of tumor samples obtained from fine needle aspirates or core needle biopsies for the establishment of patient-derived xenograft models (Abstract). Roife teaches that many cancer patients do not undergo surgery, which limits the utility of patient-derived xenograft models that rely on surgical samples (p 1246, col 2, para 2). Roife teaches that a needle biopsy allows for the procurement of tumor samples from patients who are not surgical candidates (p 1253, col 1, para 1).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hollingshead, in view of Freshney and Sun, by performing a needle biopsy to obtain the tumor sample, as taught in Roife. One of ordinary skill in the art would have been motivated to make this modification because Roife teaches that needle biopsies allow for the procurement of tumor samples in patients who are not surgical candidates. One of ordinary skill in the art would have had a reasonable expectation of successfully making this modification because Roife teaches that tumor samples can be obtained from patients using a needle biopsy.
Roife is silent as to the concentration of primary tumor cells in the tumor sample.
Cajulis teaches that fine-needle aspiration from lymph nodes of patients with diagnosed with malignant non-Hodgkin’s lymphoma yields 1.55x106 cells to 7x107 cells per tube (Abstract; p 43, col 2, para 3). Roy-Chowdhuri teaches that samples obtained from fine-needle aspirates from patients with malignant tumors comprise 25-90% tumor cells (p 502, Table 1). Therefore, a sample obtained from a fine-needle biopsy, as taught in Roife, would contain 3.9x105 to 6.3x107 tumor cells.
Freshney teaches that tumor biopsies can be resuspended in 1mL of growth medium for freezing and storage, and subsequent culturing (p 465, Protocol 24.1). Therefore, a sample obtained from a fine-needle biopsy, as taught in Roife, would have a concentration of 3.9x105 tumor cells/mL to 6.3x107 tumor cells/mL when resuspended in 1mL of growth medium.
When claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05(1).
Response to Arguments
RE: Rejections under 35 U.S.C. 103, including Declaration under Rule 37 CFR 1.132
Applicant argues: Compared with Hollingshead, the differential technical differences between the present application and Hollingshead include, but are not limited to: 1) the specific components and
concentrations thereof of the composition in claim 1: (2) cultivating the primary tumor cells with a mitomycin C-treated mouse embryonic fibroblast (MEF); (3) no restrictions on the types of antitumor drugs screened. Therefore, the technical problem addressed by the application is to provide a method for cultivating tumor cells that are used for screening anti-tumor drugs for the human patient having a tumor.
In response: Applicant’s arguments have been fully considered, but are not persuasive. Regarding differences (1) and (2), the secondary references cited in the claim rejections under 35 USC 103 teaches said limitations. Sun teaches the specific components and concentrations thereof of the composition in claim 1 (difference 1), and Freshney teaches cultivating the primary tumor cells with a mitomycin C-treated mouse embryonic fibroblast (MEF) (difference 2).
In response to applicant's argument that the references fail to show certain features of the invention (difference 3), it is noted that the features upon which applicant relies (i.e., restrictions on the types of antitumor drugs screened) 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 argues: We can see from the Examples in Sun that different components of the culture mediums and different feeder layer cells would affect the cultivation results of the tumor cells (see Para [0051-0060], [0080-0081] of Sun). It indicates that we can't take the combination of culture mediums with different components in other methods for granted without experiments and data. In order to prove the point, the Applicant has prepared an experiment to compare culture mediums with different components, which is also submitted in Declaration under Rule 37 CFR 1.132 (hereinafter "Declaration") provided by the inventor, Dr. Danyi Wen, demonstrate the unexpected results from the claimed features.
In response: Applicant’s Declaration, and the arguments directed thereto, have been fully considered. The Declaration is insufficient to overcome the grounds of rejection under 35 USC 103.
The experiment in the Declaration compares the performance of the following culture media: (A) Culture medium with components in claim l of the present application, but without NEAA and Glutamax; (B) Culture medium with components in claim l; (C) Standard F culture medium from Sun; (D) Improved F culture medium from Sun; (E) Culture medium with components in claim l of the present application, but Glutamin instead of Glutamax (p 2 of Declaration). The results demonstrate that Group B (i.e., the culture medium with components in claim 1) exhibited the most potent proliferation-promoting effect on PDX-derived primary tumor cells (p 3 of Declaration). However, the issue is not whether the culture medium of instant claim 1 (Group B) outperforms the culture media of Sun (Groups C and D), or culture media of instant claim 1 without NEAA an Glutamax (Group A) or with Glutamin instead of Glutamax (Group E). As set forth in the rejection of claim 1 under 35 USC 103, the culture medium of Sun does not comprise Non-Essential Amino Acids Solution or L-alanyl-L-glutamine dipeptide. However, as set forth in the rejection, it would have been prima facie obvious to modify the medium of Sun by adding Non-Essential Amino Acids Solution or L-alanyl-L-glutamine dipeptide, as taught by Takahashi and Cluntun, to arrive at the culture medium of claim 1 (i.e., the culture medium termed “Group B” in the Declaration).
The elements recited in the composition of claim 1 is taught in the prior art, as set forth in the rejection of the claims under 35 USC 103. There is no distinction between the elements which are claimed and the elements taught in the prior art; therefore, any properties that are exhibited by the claimed composition would be the same as those exhibited in the composition taught in the prior art. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). See MPEP 2112.01(I).
Applicant argues: It is not obvious to a person of ordinary skill in the art to obtain the technical solutions of claim 1 in the present application because the combination of the cited documents cannot obtain the composition in claim 1. Meanwhile, in view of the use of the method in claim 1 in the present application, the more rapidly the tumor cells grow, the shorter the time the patient receives treatment. It is
known for a person skilled in the art that therapeutic time is very precious for patients who have a tumor.
Thus, the culture medium exhibits surprising technical effects over the culture mediums from other
Documents (p 9 of Remarks).
In response: Applicant’s arguments have been fully considered, but are not persuasive. As set forth above and in the claim rejections under 35 USC 103, the composition recited in claim 1 is rendered obvious over the prior art. As set forth above, the issue is not whether the culture medium of claim 1 exhibits surprising technical effects over the culture mediums from other documents, when said other culture media are taken in piecemeal, but that the cited prior art, taken as a whole, renders obvious the culture medium of claim 1. Regarding the duration of therapeutic time, it is noted that the features upon which applicant relies (i.e., the preciousness of therapeutic time for patients who have a tumor) 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 argues: The method in the present application can be used to screen the anti-tumor cells which are not limited to chemotherapeutic agents, but also can screen the biological agents such as Bevacizumab (see Example 1 and Table 2), so this is another surprising technical effects for the method
in claim 1 of the present application, which cannot be taught by the combination of Hollingshead, Freshney, Sun, Takahashi, and Clunton. Therefore, claim 1 is not obvious, complying with the requirement of 35 US.C.103 (p 9 of Remarks).
In response: Applicant’s arguments have been fully considered, but are not persuasive. 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., that the method in the present application can be used to screen the anti-tumor cells which are not limited to chemotherapeutic agents, but also can screen biological agents such as Bevacizumab) 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Risa Takenaka whose telephone number is (571)272-0149. The examiner can normally be reached M-F, 12-7 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RISA TAKENAKA/Examiner, Art Unit 1632
/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
Prosecution Insights