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 .
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 2/23/26 are acknowledged. Any rejection or objection from the 10/23/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, the species of human serum albumin was elected.
Claims 9-10 have been added as new claims.
Claims 1-10 are being examined.
Priority
The priority information is found in the filing receipt dated 3/6/25.
Claim Rejections - 35 USC § 112
The rejection below is new and necessitated by amendment.
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 1-8 and 10 are rejected 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.
Claim 1 has been amended to recite ‘subject is at risk of developing cisplatin-induced nephrotoxicity and body weight loss’. Dependent claims 2-8 incorporate such language.
New claim 10 recites ‘subject is at risk of developing cisplatin-induced nephrotoxicity and body weight loss’.
It is unclear if any risk determination is made before administration or if what is recited is merely an outcome of the recited steps. The claims do require a subject (who would have mass) and recite administering a cisplatin containing composition. It is unclear if a particular subject is to be identified before administration and it is unclear how such identification would occur. It is unclear if any subjects are excluded because all subjects have mass and as claimed cisplatin is administered.
Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification.
The rejection below is new and necessitated by amendment.
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 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection is a ‘new matter’ rejection. Section 2163 of the MPEP states: ‘While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure’.
Claim 1 has been amended to recite ‘subject is at risk of developing cisplatin-induced nephrotoxicity and body weight loss’. Dependent claims 2-8 incorporate such language.
New claim 10 recites ‘subject is at risk of developing cisplatin-induced nephrotoxicity and body weight loss’ and ‘reduces the nephrotoxicity and body weight loss’.
As set forth above, the claims are unclear.
The word ‘risk’ could not be located in the instant specification. To the extent that the wherein clause that recites ‘risk’ requires a specific claim limitation, the specification does not provide express or implicit disclosure for identifying subjects at certain risks. There is no mention of risk nor are any methods or factors to consider as to how to determine risk.
As such, there is no reason to conclude that claims 1-8 and 10 are supported in the specification through express, implicit, or inherent disclosure for at least the reasons discussed above.
New claim 9 recites ‘glioma having secreted protein acidic and rich in cysteine (SPARC) expression equal to or higher than that of U87MG cells’.
The phrase ‘expression’ is broad and encompasses the expression of DNA, RNA and protein. The phrase ‘higher than’ is broad and encompasses expression that is 2x higher as well as 20000000000000x higher. The phrase ‘expression equal to or higher than that of U87MG cells’ is broad and encompasses expression at any point in time under any conditions and measuring any type of expression using any type of assay
The instant specification (section 0006 of the PGPub) recites ‘SPARC has high expression’ and recites that ‘U87MG-shSPARC cells, which exhibit low expression of SPARC protein’. However, such statements are not the equivalent of nor do they provide adequate support for the language in instant claim 9. Claim 9 refers to expression higher than that of U87MG cells, not only equivalent to U87MG cells under certain conditions.
The instant figures relate to measuring cell uptake, cytotoxicity, apoptosis and anti-tumor activity (see brief description of the drawings sections 0024-0032 of the PGPub). Claim 9 refers to expression which is different from cell uptake, cytotoxicity, apoptosis and anti-tumor activity. There does not appear to be any indication that any type of expression (DNA, RNA or protein) was assessed using any type of assay.
As such, there is no reason to conclude that claim 9 is supported in the specification through express, implicit, or inherent disclosure for at least the reasons discussed above.
Response to Arguments - 112
Applicant's arguments filed 2/23/26 have been fully considered but they are not persuasive with respect to the rejections set forth above.
Although applicants argue that the phrase, “expression equal to or higher than that of U87MG cells” has been deleted, instant claim 9 includes such phrase.
Claim Rejections - 35 USC § 103
Claims were previously rejected based on the references cited below. Since the claims have been amended the rejection is updated to correspond to the instant claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al. (‘Gel electrophoresis in combination with laser ablation-inductively coupled mass spectrometry to quantify the interaction of cisplatin with human serum albumin’ Electrophoresis v40 2019 pages 2329-2335; ‘Sullivan’) in view of Park et al. (‘Secreted protein acidic and rich in cysteine mediates active targeting of human serum albumin in U87MG xenograft mouse models’ Theranostics v9(24) 2019 pages 7447-7457; ‘Park’).
Sullivan teach cisplatin is widely used in the treatment of cancer (abstract). Sullivan teach that cisplatin and its derivatives are currently used in 50% of cancer treatments (page 2329 first paragraph of introduction). Sullivan teach that human serum albumin (HSA) is a well established transporter and also known to be a drug transporter to tumors (last paragraph on page 2329). Sullivan teach that HSA and cisplatin were incubated at various ratios including 1:10 (section 2.2 and figure 3). Sullivan teach that at the 1:10 ratio (HSA:cisplatin) that there were 4.2 Pt bound per HSA (section 4 first paragraph and figure 4). Sullivan teach n-mers were only minor species and that it can be concluded that under the conditions used HSA was present in solution primarily as the monomer and dimer (paragraph connecting pages 2332-2333).
Sullivan does not teach an example of administration to a subject with a glioma.
Park teach human serum albumin (HSA) as a versatile tool for drug delivery based on its ability to accumulate in tumors (abstract). Park specifically recognizes the use of a drug carrier and specifically recites the albumin based medicine nab-paclitaxel (page 7448 first paragraph). Park teach that SPARC has been postulated to sequester albumin in tumor stroma and teach that SPARC is an albumin binding protein that is highly expressed in various cancers (2nd paragraph on page 7448). Park teach that the uptake of HSA in U87MG glioblastoma cells was assessed (2nd paragraph of abstract on page 7447) and teach that SPARC enhances HSA accumulation in U87MG glioma and mediates active targeting of HSA in tumors (last paragraph of page 7447). Park teach that the study has shown the potential of HSA as a therapeutic agent for glioma and that HSA-mediated drug delivery to glioma represents a promising strategy (page 7454 first complete paragraph). Park specifically teach that the SPARC protein expression in U87MG cells was assessed (figure 1 and pages 7454-7455 connecting paragraph). Park teach that U87MG generally express high levels of SPARC (abstract methods section). Park teach that previous studies have shown a correlation between SPARC and HSA at the protein expression level in cancer cells and that the instant study showed binding between HSA and SPARC and confirmed the direct relationship between SPARC and HSA and observed SPARC-mediated HSA accumulation in tumor tissues (page 7452 last paragraph). Park teach that HSA could accumulate in tumors by active targeting through SPARC expression (page 7453 first paragraph) and that HSA accumulation in U87MG glioma correlates with SPARC expression (page 7454 conclusion section). Park teach that the high uptake of HSA in U87MG was dependent on SPARC expression (page 7452 first paragraph). Park teach that SPARC mediates HSA accumulation in U87MG glioma cells that express high levels of SPARC (page 7453, first complete paragraph of column 2). Park teach that SPARC enhances HSA accumulation in U87MG glioma and mediates active targeting of HSA in tumors (abstract conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Sullivan because Sullivan teach cisplatin is widely used in the treatment of cancer (abstract) and teach that cisplatin and its derivatives are currently used in 50% of cancer treatments (page 2329 first paragraph of introduction). Since Sullivan teach that human serum albumin (HSA) is a well established transporter and also known to be a drug transporter to tumors (last paragraph on page 2329) and teach conjugation with cisplatin (section 4 first paragraph and figure 4) one would have been motivated to use such conjugate. With respect to the specific use, Park teach that the uptake of HSA in U87MG glioblastoma cells was assessed (2nd paragraph of abstract on page 7447) and teach that SPARC enhances HSA accumulation in U87MG glioma and mediates active targeting of HSA in tumors (last paragraph of page 7447). Park teach that the study has shown the potential of HSA as a therapeutic agent for glioma and that HSA-mediated drug delivery to glioma represents a promising strategy (page 7454 first complete paragraph). Further, Park specifically teach that the SPARC protein expression in U87MG cells was assessed (figure 1 and pages 7454-7455 connecting paragraph). Park teach that HSA could accumulate in tumors by active targeting through SPARC expression (page 7453 first paragraph) and that HSA accumulation in U87MG glioma correlates with SPARC expression (page 7454 conclusion section). Park teach that the high uptake of HSA in U87MG was dependent on SPARC expression (page 7452 first paragraph). Park teach that SPARC mediates HSA accumulation in U87MG glioma cells that express high levels of SPARC (page 7453, first complete paragraph of column 2). Park teach that SPARC enhances HSA accumulation in U87MG glioma and mediates active targeting of HSA in tumors (abstract conclusion). Thus, one would have been motivated to use the conjugate taught by Sullivan for the suggested treatment taught by Park. Further, one would have been motivated to administer to those with high SPARC expression levels based on the advantages disclosed by Park (enhanced accumulation and uptake). One would have had a reasonable expectation of success since Sullivan teach cisplatin is widely used in the treatment of cancer (abstract) and teach that cisplatin and its derivatives are currently used in 50% of cancer treatments (page 2329 first paragraph of introduction). Further, Park teach human serum albumin (HSA) as a versatile tool for drug delivery based on its ability to accumulate in tumors (abstract). Park teach that the uptake of HSA in U87MG glioblastoma cells was assessed (2nd paragraph of abstract on page 7447) and teach that SPARC enhances HSA accumulation in U87MG glioma and mediates active targeting of HSA in tumors (last paragraph of page 7447). Park teach that the study has shown the potential of HSA as a therapeutic agent for glioma and that HSA-mediated drug delivery to glioma represents a promising strategy (page 7454 first complete paragraph).
In relation to the albumin cisplatin conjugate of claims 1 and 9-10, Sullivan teach that HSA and cisplatin were incubated at various ratios including 1:10 (section 2.2 and figure 3). Sullivan teach that at the 1:10 ratio (HSA:cisplatin) that there were 4.2 Pt bound per HSA (section 4 first paragraph and figure 4).
In relation to the subject and cancer and administration as recited in claims 1 and 9-10, Park teach that the study has shown the potential of HSA as a therapeutic agent for glioma and that HSA-mediated drug delivery to glioma represents a promising strategy (page 7454 first complete paragraph). Park teach that the uptake of HSA in U87MG glioblastoma cells was assessed (2nd paragraph of abstract on page 7447). Park specifically teach that the SPARC protein expression in U87MG cells was assessed (figure 1 and pages 7454-7455 connecting paragraph). Park teach that HSA could accumulate in tumors by active targeting through SPARC expression (page 7453 first paragraph) and that HSA accumulation in U87MG glioma correlates with SPARC expression (page 7454 conclusion section). Park teach that the high uptake of HSA in U87MG was dependent on SPARC expression (page 7452 first paragraph). Park teach that SPARC mediates HSA accumulation in U87MG glioma cells that express high levels of SPARC (page 7453, first complete paragraph of column 2). Park teach that SPARC enhances HSA accumulation in U87MG glioma and mediates active targeting of HSA in tumors (abstract conclusion). Thus, one would have been motivated to administer to those with such SPARC expression levels based on the advantages disclosed by Park (enhanced accumulation and uptake). As noted above, the claims are unclear. The prior art suggest subjects (who would have mass and would be at risk of weight loss) and suggests administration of cisplatin (so subjects would be at risk of cisplatin induced effects). Since the prior art suggest the active steps as claimed the claim limitations are interpreted as being met.
In relation to claims 2-7, Sullivan teach that HSA and cisplatin were incubated at various ratios including 1:10 (section 2.2 and figure 3). Sullivan teach that at the 1:10 ratio (HSA:cisplatin) that there were 4.2 Pt bound per HSA (section 4 first paragraph and figure 4). Such ratio is the same ratio as used in the instant specification (see 2nd paragraph of section 1.2) MPEP 2112.01 II recognizes that a chemical composition and its properties are inseparable.
In relation to claim 8, Park teach that the uptake of HSA in U87MG glioblastoma cells was assessed (2nd paragraph of abstract on page 7447).
Response to Arguments - 103
Applicant's arguments filed 2/23/26 have been fully considered but they are not persuasive.
Although applicants argue about a subject at risk, instant claim 9 makes no mention of risk. Further, as set forth above the claims are unclear. Claim 1 refers to a risk of cisplatin-induced nephrotoxicity and body weight loss. Since the claim already requires a subject (who has mass) and cisplatin administration, it is unclear how or if the newly added claim language alters the claim scope. It is unclear what subjects are excluded by the last wherein clause of claim 1 for example. Since the prior art suggest the active steps as claimed the claim limitations are interpreted as being met.
Although applicants argue about comparisons to administration of cisplatin alone, the instant claims require administration of a conjugate. 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., cisplatin alone) are not recited in the rejected claim 1. 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).
Although applicants argue about BUN levels, staining images and TUNEL assays, it is noted that the features upon which applicant relies (i.e., BUN levels, staining images and TUNEL assays) 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).
Although applicants argue that the claims have been amended, the amended claims are addressed above.
Although applicants argue that the amended claim limitations reflect the actual threshold at which the inventive method becomes effective, the active step of claim 9 is ‘administering’. Claim 9 does refer to expression, but does not use the word threshold.
Although applicants argue that Park does not disclose any therapeutic use or any cisplatin-albumin conjugate, the instant rejection is a multiple reference 103 rejection and as such any single reference does not necessarily anticipate the claims. Further, Park teach human serum albumin (HSA) as a versatile tool for drug delivery based on its ability to accumulate in tumors (abstract). Park specifically recognizes the use of a drug carrier and specifically recites the albumin based medicine nab-paclitaxel (page 7448 first paragraph).
Although applicants argue that Park does not suggest the key feature of the claims related to efficacy and SPARC expression, Park specifically teach that the SPARC protein expression in U87MG cells was assessed (figure 1 and pages 7454-7455 connecting paragraph). Park teach that U87MG generally express high levels of SPARC (abstract methods section). Park teach that previous studies have shown a correlation between SPARC and HSA at the protein expression level in cancer cells and that the instant study showed binding between HSA and SPARC and confirmed the direct relationship between SPARC and HSA and observed SPARC-mediated HSA accumulation in tumor tissues (page 7452 last paragraph). Park teach that HSA could accumulate in tumors by active targeting through SPARC expression (page 7453 first paragraph) and that HSA accumulation in U87MG glioma correlates with SPARC expression (page 7454 conclusion section). Park teach that the high uptake of HSA in U87MG was dependent on SPARC expression (page 7452 first paragraph). Park teach that SPARC mediates HSA accumulation in U87MG glioma cells that express high levels of SPARC (page 7453, first complete paragraph of column 2). Park teach that SPARC enhances HSA accumulation in U87MG glioma and mediates active targeting of HSA in tumors (abstract conclusion). Thus, Park provides a wealth of information.
Although applicants argue that Sullivan alone does not teach the claim limitations, the instant rejection is a multiple reference 103 rejection and as such any single reference does not necessarily anticipate the claims. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Although applicants allude to an unexpected result, MPEP 716.02(b) recognizes that the burden is on the applicant to establish results are unexpected and significant. It is unclear what specific result is deemed unexpected and why it is deemed to be unexpected. Park specifically teach that the SPARC protein expression in U87MG cells was assessed (figure 1 and pages 7454-7455 connecting paragraph). Park teach that U87MG generally express high levels of SPARC (abstract methods section). Park teach that previous studies have shown a correlation between SPARC and HSA at the protein expression level in cancer cells and that the instant study showed binding between HSA and SPARC and confirmed the direct relationship between SPARC and HSA and observed SPARC-mediated HSA accumulation in tumor tissues (page 7452 last paragraph). Park teach that HSA could accumulate in tumors by active targeting through SPARC expression (page 7453 first paragraph) and that HSA accumulation in U87MG glioma correlates with SPARC expression (page 7454 conclusion section). Park teach that the high uptake of HSA in U87MG was dependent on SPARC expression (page 7452 first paragraph). Park teach that SPARC mediates HSA accumulation in U87MG glioma cells that express high levels of SPARC (page 7453, first complete paragraph of column 2). Park teach that SPARC enhances HSA accumulation in U87MG glioma and mediates active targeting of HSA in tumors (abstract conclusion).
Although applicants argue that Sullivan alone does not teach administration to subjects as claimed, the instant rejection is a multiple reference 103 rejection and as such any single reference does not necessarily anticipate the claims. Park et al. (‘Secreted protein acidic and rich in cysteine mediates active targeting of human serum albumin in U87MG xenograft mouse models’ Theranostics v9(24) 2019 pages 7447-7457; ‘Park’; previously cited) teach that the study has shown the potential of HSA as a therapeutic agent for glioma and that HSA-mediated drug delivery to glioma represents a promising strategy (page 7454 first complete paragraph).
Although applicants argue about a reasonable expectation of success, the instant claims are drawn to ‘treating a glioma’. MPEP 2143.02 recognizes that absolute predictability and conclusive proof of efficacy is not required. In the instant case, Sullivan teach cisplatin is widely used in the treatment of cancer (abstract). Sullivan teach that cisplatin and its derivatives are currently used in 50% of cancer treatments (page 2329 first paragraph of introduction). Sullivan teach that human serum albumin (HSA) is a well established transporter and also known to be a drug transporter to tumors (last paragraph on page 2329). Park et al. (‘Secreted protein acidic and rich in cysteine mediates active targeting of human serum albumin in U87MG xenograft mouse models’ Theranostics v9(24) 2019 pages 7447-7457; ‘Park’; previously cited) teach human serum albumin (HSA) as a versatile tool for drug delivery based on its ability to accumulate in tumors (abstract). Park further teaches that albumin-based nanomedicine was approved for the treatment of breast cancer in 2005, non-small cell lung cancer in 2012 and pancreatic cancer in 2014 and further states that the success has shown the potential of albumin as a drug carrier for tumor therapy (page 7448 first paragraph). MPEP 2107.03 IV recites that: “Before a drug can enter human clinical trials, the sponsor, often the applicant, must provide a convincing rationale to those especially skilled in the art (e.g., the Food and Drug Administration (FDA)) that the investigation may be successful. Such a rationale would provide a basis for the sponsor’s expectation that the investigation may be successful. In order to determine a protocol for phase I testing, the first phase of clinical investigation, some credible rationale of how the drug might be effective or could be effective would be necessary. Thus, as a general rule, if an applicant has initiated human clinical trials for a therapeutic product or process, Office personnel should presume that the applicant has established that the subject matter of that trial is reasonably predictive of having the asserted therapeutic utility”. In the instant case, Sullivan teach cisplatin is widely used in the treatment of cancer (abstract). Sullivan teach that cisplatin and its derivatives are currently used in 50% of cancer treatments (page 2329 first paragraph of introduction). Sullivan teach that human serum albumin (HSA) is a well established transporter and also known to be a drug transporter to tumors (last paragraph on page 2329). Park et al. (‘Secreted protein acidic and rich in cysteine mediates active targeting of human serum albumin in U87MG xenograft mouse models’ Theranostics v9(24) 2019 pages 7447-7457; ‘Park’; previously cited) teach human serum albumin (HSA) as a versatile tool for drug delivery based on its ability to accumulate in tumors (abstract). Park further teaches that albumin-based nanomedicine was approved for the treatment of breast cancer in 2005, non-small cell lung cancer in 2012 and pancreatic cancer in 2014 and further states that the success has shown the potential of albumin as a drug carrier for tumor therapy (page 7448 first paragraph). Further, Holding et al. (‘Phase I trial of cisplatin-albumin complex for the treatment of cancer of the head and neck’ Br J clin Pharmac v33 1992 pages 75-81) (this article was cited in parent application 17/677,162) teach a phase I trial of cisplatin-albumin for the treatment of end-stage squamous cell carcinoma (abstract) and teach that the complex retains activity with improved quality of life (abstract section 4 and page 79 2nd complete paragraph).
Although applicants allude to the use of hindsight, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Although applicants argue a lack of motivation to target a defined patient population, Park teach that the uptake of HSA in U87MG glioblastoma cells was assessed (2nd paragraph of abstract on page 7447) and teach that SPARC enhances HSA accumulation in U87MG glioma and mediates active targeting of HSA in tumors (last paragraph of page 7447). Park teach that the study has shown the potential of HSA as a therapeutic agent for glioma and that HSA-mediated drug delivery to glioma represents a promising strategy (page 7454 first complete paragraph). Park specifically teach that the SPARC protein expression in U87MG cells was assessed (figure 1 and pages 7454-7455 connecting paragraph). Park teach that U87MG generally express high levels of SPARC (abstract methods section). Park teach that previous studies have shown a correlation between SPARC and HSA at the protein expression level in cancer cells and that the instant study showed binding between HSA and SPARC and confirmed the direct relationship between SPARC and HSA and observed SPARC-mediated HSA accumulation in tumor tissues (page 7452 last paragraph). Park teach that HSA could accumulate in tumors by active targeting through SPARC expression (page 7453 first paragraph) and that HSA accumulation in U87MG glioma correlates with SPARC expression (page 7454 conclusion section). Park teach that the high uptake of HSA in U87MG was dependent on SPARC expression (page 7452 first paragraph). Park teach that SPARC mediates HSA accumulation in U87MG glioma cells that express high levels of SPARC (page 7453, first complete paragraph of column 2). Park teach that SPARC enhances HSA accumulation in U87MG glioma and mediates active targeting of HSA in tumors (abstract conclusion).
Conclusion
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 RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
Prosecution Insights