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
Change of Examiner
The examiner assigned to the instant application has changed. The new examiner is Bong-Sook Baek. Contact information is provided at the end of this Office Action.
Status of Claims
Claims 1-13 are pending.
Election/Restrictions
Applicants’ election of Group I, in the reply filed on 1/8/2026 is acknowledged. The election was made without traverse.
Accordingly, claims 9-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Claims 1-8 are under examination in the instant office action.
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (Korean Society of Food Preservation, 25(4): 471-481, 2018).
Park et al. disclose that several studies have indicated cytotoxic activities of the extract of Dendropanax morbifera (DP) on a number of human cancers such as breast cancer, lung cancer, hepatoma, and chorioepithelioma (abstract). Park et al. disclose anti-cancer activity of isolated triterpenoids form the DP leaves in MCF-7 human breast cancer wherein they showed cytotoxic activities toward the cancer cell lines while they were safe to normal cells (abstract).
Park et al. disclose the triterpenoids are isolated from n-hexane fraction which was prepared from extracts of DP obtained from DP leaves (p473, col 1, para 2). The isolated six triterpenoids from the n-hexane fraction of DP leaves include the known compounds. β-amyrin (1), α-amyrin (2), olean-12-en-3,24 β-diol (3), dendropanoxide (4), β-sitosterol (5), and stigmasterol (6) (abstract). Park et al. further disclose α-amyrin and β-amyrin actively arrested progression of the cell cycle and induces apoptosis in MCF-7 and A-549 cells (p479, col 1, para 2).
Park et al. also teach that inhibition of cancer growth has been a continuous effort in cancer treatment and the in vitro cytotoxicity of the isolated compounds showed its significant anti-cancer activity against MCF-7 and A549 cells (p479, col 1 para 3).
In addition, Park et al. teach that the results of the present study revealed that triterpenoids from DP have the potential for further development as anticancer agents (abstract).
While the prior art does not specifically disclose an embodiment of treating breast cancer in a subject in need thereof by administering the extract or fraction of DP, the prior art specifically discloses cytotoxic and pro-apoptotic effects of the compounds isolated from n-hexane fraction of DP on breast cancer cells. In addition, the prior art suggests the use of DP extract as anticancer agent. Thus, one of ordinary skill in the art would have been motivated to use the extract or n-hexane fraction of DP leaves containing triterpenoids having anti-cancer activities for treating a subject with breast cancer on the reasonable expectation of success based on their cytotoxic effects on human breast cancer cells in vitro and induction of apoptosis of the cancer cells.
As to claim 5-7, the claims further recite intended results of the claimed methods (i.e., “inhibit growth of breast cancer stem cells” in claim 5, “inhibit formation of breast cancer-derived mammospheres or inhibits proliferation of breast cancer-derived mammospheres” in claim 6, “inhibits expression of a c-Mye gene or protein” in claim 7, those are intended results of the active method step (i.e., administering the composition to a subject), and as such are non-limiting since language does not result in manipulative difference in steps of claims. The reference teaches, suggests or motivates the same method step as instantly claimed (i.e. administering a composition comprising the same DP extract or fraction to the same breast cancer subject), thus such intended results necessarily occur when the same composition is administered to the same subject as taught and suggest by the prior art. It is noted that products of identical chemical composition cannot have mutually exclusive properties and a chemical composition and its properties are inseparable. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) “would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art.” 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness, however the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.).“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) (“The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.”). In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) discussed in MPEP § 2144 are also pertinent to this issue.
Claims 1 and 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Im et al. (J Korean Obstet Gynecol, 28(2): 26-39, 2015).
Im et al. disclose a study to investigate the anti-cancer effects of water extract of Dendropanax morbifera (DP) on two human breast cancer cell lines (estrogen dependent MCF-7 and estrogen independent MDA-MB-231) (abstract). Im et al. disclose DP inhibits the cell growth in a dose dependent manner (0, 50, 100, 250, and 500 μg/ml) of both estrogen independent MDA-MB-231 and estrogen dependent MCF-7 breast cancer cells (abstract). Im et al. conclude that these results indicate that DP extract are source of anti-cancer potential and could be developed botanical drug (abstract).
While the prior art does not specifically disclose an embodiment of treating breast cancer in a subject in need thereof by administering the extract or fraction of DP, the prior art specifically discloses anti-cancer activities of the water extract/fraction of DP in breast cancer cells. In addition, the prior art suggests the use of DP extract as anticancer agent. Thus, one of ordinary skill in the art would have been motivated to use the water extract of DP for treating a subject with breast cancer on the reasonable expectation of success based on its cytotoxic activities in human breast cancer cells in vitro.
As to claim 5-7, the claims further recite intended results of the claimed methods (i.e., “inhibit growth of breast cancer stem cells” in claim 5, “inhibit formation of breast cancer-derived mammospheres or inhibits proliferation of breast cancer-derived mammospheres” in claim 6, “inhibits expression of a c-Mye gene or protein” in claim 7, those are intended results of the active method step (i.e., administering the composition to a subject), and as such are non-limiting since language does not result in manipulative difference in steps of claims. The reference teaches, suggests or motivates the same method step as instantly claimed (i.e. administering a composition comprising the same DP extract or fraction to the same breast cancer subject), thus such intended results necessarily occur when the same composition is administered to the same subject as taught and suggest by the prior art. It is noted that products of identical chemical composition cannot have mutually exclusive properties and a chemical composition and its properties are inseparable. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) “would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art.” 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness, however the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.).“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) (“The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.”). In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) discussed in MPEP § 2144 are also pertinent to this issue.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (Korean Society of Food Preservation, 25(4): 471-481, 2018) as evidenced by Camerlingo et al. (Oncology Reports, 31 (3): 1127-1132, 2014).
Park et al. as applied supra is herein applied for the same teachings in their entirety.
The prior art is silent about breast cancer expressing CD44high/CD22low. However, it was known in the art that many malignant tumors contain heterogeneous cell population with diverse biological properties and within these there is small proportion of tumor cells termed cancer stem cells (CSCs) and in breast cancer patient, cells that have a strong expression of the adhesion molecule CD44 together with very low levels or no expression of the adhesion molecule CD24 (CD44+/CD24−/low phenotype) are readily detectable and the cells showing this antigenic profile, were able to form mammospheres, and were resistant to drug administration as evidenced by Camerlingo et al. (abstract and Table 1). Camerlingo et al. further teach that CD44+/CD24-/low profile correlates with the more aggressive clinical-pathological features of breast cancer (abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the DP extract or fraction having cytotoxic and pro-apoptotic effects on breast cancer cells for treating breast cancer having cells expressing CD44high/CD22low because such cells were known to be present in most of breast cancers as evidenced by Camerlingo et al. Thus, one of ordinary skill in the art would have been motivated to do so on the reasonable expectation that the composition would be similarly effective for breast cancer having a small portion of cells expressing CD44high/CD22low in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONG-SOOK BAEK whose telephone number is 571-270-5863. The examiner can normally be reached 9:00AM-6:00PM Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611