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 .
Priority
The instant application is a national stage entry of PCT/EP2013/066254 filed on 2/16/2021.
Power of Attorney
Applicant has not filed a Power of Attorney and it is recommended that one is submitted to facilitate prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/14/2023 is in compliance with the provisions of 37 C.F.R. 1.97. All references cited in said IDS have been fully considered.
Claim Objections
Claim 19 is objected to because of the following informality: the word “of” after “increases” in line 2 should be deleted.
Claim 22 recites the limitation “the active recombinant placental alkaline phosphatase” (emphasis added) but the parent claim does not recite an active recombinant placental alkaline phosphatase. To maintain consistency with the rest of the claims, applicant should delete “active” in claim 22.
Claim 25 is objected to due to an unnecessary use of “or” after the words “chloride solution”. It is recommended that line 2 be amended to “chloride solution, a liposomal preparation, or a nanoparticle preparation” in order to delete the first “or” and insert commas.
Claim 28 is objected to since the number in the unit “m2” is not in superscript. To resolve this issue, the three “m2” in line 3 should be replaced with “m2”.
Claim 29 is objected to because recitation of “a” after “one” is redundant. It is recommended that “one” be deleted.
Claim 30 is objected to since a hyphen is missing between the words “cyclophosphamide containing”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 17-19, 21-24, 26-27, and 29-32 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Furlan Freguia et al. (Pub. No. WO 2020/227263 A1).
Furlan Freguia et al. discloses methods and compositions for preventing, treating, or reducing chemotherapy-mediated side effects (Abstract).
One aspect of the methods is treating or preventing at least one side effect of a chemotherapeutic treatment having a nucleoside analog in a subject comprising administering to the subject an intestinal alkaline phosphatase, wherein the subject has undergone or is undergoing treatment of a cancer using the chemotherapeutic treatment (lines 4-7, page 2). The side effect includes anemia and myelosuppression (lines 28-32, page 2; lines 11-16, page 4; lines 25-28, page 31).
The disclosed methods are not limited to use of intestinal alkaline phosphatase since any polypeptide with alkaline phosphatase activity can be employed including recombinant alkaline phosphatases, modified alkaline phosphatases, and mammalian alkaline phosphatases like human placental alkaline phosphatase (lines 5-13, page 5; lines 26-37, page 7; lines 28-39, page 13). The alkaline phosphatase-based agent can comprise mutations such that it possesses desired characteristics like enhanced activity and/or stability such as in the gastrointestinal tract (lines 1-7 and 15-17, page 21). To make recombinant alkaline phosphatases, nucleic acids encoding the alkaline phosphatase can be transformed into any type of host cell, including mammalian, bacterial, yeast, insect, and/or fungal cells (lines 3-5, page 23).
The alkaline phosphatase-based agent can be administered as a component of a composition containing a pharmaceutically acceptable carrier and optionally a pharmaceutical excipient such as saline (lines 4-10, page 23). In some embodiments, the composition comprises an additional agent like a stem cell transplant (lines 13-17, page 35; lines 5-6, page 37).
Administration of the alkaline phosphatase and/or a pharmaceutical composition thereof can be any one of oral, intravenous, and parenteral. Examples of suitable route of administration include intravenous, subcutaneous, and intramuscular (lines 24-28, page 24). Administration can be systemic or local (lines 14-16, page 27) and can occur about once per day, every other day, about once a week, or about once every two weeks, (lines 17-21, page 30). Moreover, the alkaline phosphatase-based agent can be administered simultaneously, sequentially (prior or after), or intermittently with the administration of the chemotherapeutic treatment (lines 25-27, page 30; lines 7-11, page 31).
Furlan Freguia et al.’s method reads on the instant application’s method to manage chemotherapy care of a cancer patient as follows:
Regarding claim 17: administering alkaline phosphatase such as a placental alkaline phosphatase to a subject that has undergone or is undergoing treatment of a cancer using chemotherapeutic treatment having a nucleoside analog, wherein said alkaline phosphatase can be modified or recombinant (lines 5-11, page 5; lines 31-34, page 23; lines 1-7, page 24) and wherein the subject is a cancer patient (line 28, page 34), is equivalent to “administering recombinant placental alkaline phosphatase or highly purified human placental alkaline phosphatase to the cancer patient”.
Performing the disclosed method to treat or prevent at least one side effect of the chemotherapeutic treatment like anemia and myelosuppression (lines 28-32, page 2; lines 11-16, page 4; lines 25-28, page 31), which lowers the levels of red blood cells, white cells, and platelets, meets the intended function “to reduce chemotherapy-induced loss of red blood cells, white blood cells, or platelets, or combinations thereof”.
Regarding claim 18: the administration of alkaline phosphatase allowing the chemotherapeutic treatment to be increased in dose, length, and/or frequency (lines 14-18, page 33) is the same as “wherein administration of recombinant placental alkaline phosphatase or placental alkaline phosphatase allows using chemotherapy at higher doses or with greater frequencies, or both using chemotherapy at higher doses and with greater frequencies”.
Regarding claim 19: Furlan Freguia et al. teaches that administering alkaline phosphatase allows the subject to receive greater dose, longer treatment duration, and/or more frequent treatment of the chemotherapeutic treatment, as well receive a complete regimen of chemotherapeutic treatment, which increases the efficacy of the chemotherapeutic treatment and therefore satisfies “wherein administering recombinant placental alkaline phosphatase or highly purified human placental alkaline phosphatase increases of chemotherapy efficacy”.
Regarding claim 21: Preparing recombinant alkaline phosphatases by transforming nucleic acids encoding the alkaline phosphatase into a host cell like mammalian, bacterial, yeast, insect, and/or fungal cells (lines 3-5, page 23) corresponds to “wherein the recombinant placental alkaline phosphatase is produced by a mammalian cell, a bacterium, a yeast, or purified from cow's milk, goat's milk, chicken eggs, or plants”.
Regarding claim 22: Furlan Freguia et al. teaches that mammalian alkaline phosphatases like placental alkaline phosphatases can be left anchored to a host cell (leads to intracellular retention of the enzyme), or not anchored (results in secretion of the enzyme) such as by having mutations around the anchor site or in the hydrophobic domain, or truncating or eliminating the hydrophobic domain (lines 15038, page 7). This teaching fulfills “wherein the sequence of the active recombinant placental alkaline phosphatase is altered compared to the full length placental alkaline phosphatase”.
Regarding claim 23: the alkaline phosphatase in some embodiments is a fusion protein comprising an alkaline phosphatase fused to a protein domain that promotes protein stability and/or extended serum half-life such as one or more mutations in the Fc domain of IgG that increases serum half-life and longevity (lines 4-16, page 9). And in another embodiment, the fusion is achieved through a linker that improves the stability and/or bioactivity of the alkaline phosphatase, wherein said linker is less than about 100 amino acids long (lines 26-35, page 10; lines 1-5, page 11), which corresponds to less than 20% of the amino acid sequence of alkaline phosphatase. These teachings are considered to meet “wherein the recombinant placental alkaline phosphatase comprises a hybrid protein containing up to about 50% of an amino acid sequence of placental alkaline phosphatase sufficiently long to enhance stability in the circulation, and up to about 50% of an amino acid sequence of another alkaline phosphatase sufficiently long to provide catalytic alkaline phosphatase activity”.
Regarding claim 24: the composition comprising alkaline phosphatase and a pharmaceutically acceptable carrier (lines 4-10, page 23) being administered intravenously, subcutaneously, or intramuscularly (indicates injecting the composition; lines 24-28, page 24) about once per day, every other day, about once a week, or about once every two weeks, (lines 17-21, page 30) is akin to “wherein the recombinant placental alkaline phosphatase or placental alkaline phosphatase is administered to the cancer patient via injection in a physiologically acceptable carrier three times a week, twice a week, once a week, or biweekly independent of the length of time between two cycles of therapy”.
Regarding claim 26: suitable routes of administration include intravenous, subcutaneous, and intramuscular, thereby meeting “wherein the injection is intravenous, intra-arterial, intraperitoneal, intramuscular, intraportal, subcutaneous, or intradermal”.
Regarding claim 27: administering via direct infusion (lines 31-34, page 27) satisfies “administered via infusion or by a controlled release device”.
Regarding claim 29: the administration being systemic or local (lines 14-16, page 27), which can be done simultaneously, sequentially (prior or after), or intermittently with the administration of the chemotherapeutic treatment (lines 25-27, page 30; lines 7-11, page 31), fulfills “wherein the recombinant placental alkaline phosphatase or placental alkaline phosphatase is administered via one a systemic route prior to, during, or after administration of any cancer medication or any other medication prescribed for an indication other than cancer”.
Regarding claim 30: the alkaline phosphatase can be administered with an additional agent as a single formulation or separately either simultaneously or sequentially (lines 13-30 and 30-34, page 35), wherein the additional agent includes cyclosphosphamide (lines 17-18, page 37) which is the same as “wherein the chemotherapy administers cyclophosphamide or a cyclophosphamide containing drug composition”.
Regarding claim 31: the chemotherapeutic treatments 5-fluorouracil and capecitabine (lines 3-10, page 4; lines 20-25, page 32) induce myelosuppression, which is characterized by decreased red blood cells, white bloods cells, and/or platelets, thereby meeting “wherein chemotherapy administers any anticancer drug or combinations with other anticancer drugs that cause the cancer patient's loss of red blood cells, white blood cells, platelets, or combinations thereof”.
Regarding claim 32: administering the composition comprising an alkaline phosphatase like recombinant placental alkaline phosphatase to a subject with cancer, wherein an additional agent like a stem cell transplant can be administered sequentially such as after the alkaline phosphatase (lines 13-17 and 32-35, page 35; lines 4-5, page 36; lines 5-6, page 37), is analogous to “administering recombinant placental alkaline phosphatase or placental alkaline phosphatase to the cancer patient before transplanting hematopoietic stem cells without or with mesenchymal stem cells”.
Even though Furlan Freguia et al. does not explicitly state that the disclosed method aims “to increase the viability of the stem cells to promote formation of red blood cells, white blood cells, platelets, or combinations thereof”, the prior art teaches treating or preventing at least one side effect of the chemotherapeutic treatment such as myelosuppression. Myelosuppression causes lower levels of red blood cells, white cells, and/or platelets. By treating or preventing myelosuppression, administration of alkaline phosphatase necessarily results in increasing the viability of the stem cells and promoting the formation of these blood cells. The recited effect is inherent to the disclosed method. According to MPEP § 2112, an inherent feature does not have to recognized at the relevant time and that the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." See Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) and Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993) (The Board rejected a claim directed to a method for protecting a plant from plant pathogenic nematodes by inoculating the plant with a nematode inhibiting strain of P. cepacia. A U.S. patent to Dart disclosed inoculation using P. cepacia type Wisconsin 526 bacteria for protecting the plant from fungal disease. Dart was silent as to nematode inhibition but the Board concluded that nematode inhibition was an inherent property of the bacteria. The Board noted that applicant had stated in the specification that Wisconsin 526 possesses an 18% nematode inhibition rating.).
Claims 17-19, 21-24, 26-27, and 29-32 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Furlan Freguia et al. (Pub. No. WO 2020/227263 A1), as evidenced by Kiss (Pub. No. US 2010/0279411 A1).
Furlan Freguia et al.’s teachings are set forth above and applied herein. This prior art is found to anticipate claims 17-19, 21-24, 26-27, and 29-32.
Regarding claim 32: as described above, Furlan Freguia et al. teaches administering an additional agent such as stem cell transplant after administering the alkaline phosphatase.
Furlan Freguia et al. is different from the instant claim in that it does not explicitly teach that the disclosed method increases the viability of the stem cells to promote formation of red blood cells, white blood cells, platelets, or combinations thereof.
Nonetheless, Kiss teaches that placental alkaline phosphatase promotes survival and proliferation of stem cells before, during, and after transplantation. It also promotes bone marrow regeneration (par. [0026], [0076]-[0081]). Kiss therefore provides evidence that administering alkaline phosphatase prior to stem cell transplantation results in increasing the viability of stem cells and producing blood cells like red blood cells, white blood cells, and/or platelets.
Claim 32 is therefore anticipated by Furlan Freguia et al., as evidenced by Kiss.
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 17-32 are rejected under 35 U.S.C. 103 as being unpatentable over Furlan Freguia et al. (Pub. No. WO 2020/227263 A1) in view of Kiss (Pub. No. US 2010/0279411 A1).
The teachings of Furlan Freguia et al. are described previously and applied herein. This prior art is found to anticipate claims 17-19, 21-24, 26-27, and 29-32.
Furlan Freguia et al. is comparable to the claims below:
Regarding claim 20: the placental alkaline phosphatase in the method of claim 17 is required to be “isolated and purified from human placenta having a purity of 98% or greater”.
Furlan Freguia et al. differs from the instant claim in that it only explicitly teaches that the alkaline phosphatase can be a mammalian placental alkaline phosphatase (specifically not a human placental alkaline phosphatase).
It is known in the art, however, that human placenta synthesizes alkaline phosphatase during pregnancy and thus human placental alkaline phosphatase can be prepared by extraction from placental tissue as substantiated by Kiss (par. [0034]). Kiss teaches purifying raw extracts of said enzyme to remove contaminants (par. [0035]) such as through column chromatography, which can result in complete purification (par. [0082]-[0083]). Thus, a person with ordinary skill in the art would have extracted alkaline phosphatase from a human placenta and subject it to several rounds of column chromatography as shown by Kiss, with reasonable expectation that pure human placental alkaline phosphatase would be produced. Obviousness is based on the rationale that all claimed elements were known in the prior art and their combination would have yielded nothing more than predictable results. See MPEP § 2143 and KSR, 550 U.S. 398, 82 USPQ2d at 1395.
Hence, claim 20 is obvious over Furlan Freguia et al. in view of Kiss.
Regarding claim 25: the physiologically acceptable carrier in the method of claim 24 is further defined as “0.9% sodium chloride solution or a liposomal preparation or a nanoparticle preparation”.
The prior art teaches that the pharmaceutically acceptable carrier or excipient includes saline but does not state the concentration of sodium chloride.
Use of physiological saline in as a carrier in pharmaceutical compositions is routine in the art. For example, Kiss teaches dissolving placental alkaline phosphatase in physiological saline or 0.9% NaCl to prepare it for injection (par. [0069]). It would have thus been obvious to use 0.9% NaCl as the pharmaceutically acceptable carrier or excipient and predict that it would facilitate delivery of the alkaline phosphatase to the subject.
Regarding claim 28: the recombinant placental alkaline phosphatase or placental alkaline phosphatase is further stipulated to be “administered in therapeutically effective amounts in a range of between 0.005 to 2.5 g per m2, or between 0.05 to 1 g per m2, or between 0.1 to 1 g per m2 of the calculated patient's body surface”.
Furlan Freguia et al. teaches that the suitable dosage is about 0.01 mg of alkaline phosphatase per kg of body weight of the subject (mg/kg) to about 100 mg/kg (lines 30-31, page 29), but does not teach the dosage in terms of alkaline phosphate per m2 of the patient’s body surface.
Nevertheless, Kiss shows that the dosage for systemic administration can be calculated in grams of the active agent per square mete of body surface of the subject. For example, the therapeutically effective amount of placental alkaline phosphatase is between 0.1 to 1 gram per m2 body surface. In general, the amount depends on the type of administration and the nature of the protein (par. [0068]). Since Furlan Freguia et al. teaches that the actual dose of alkaline phosphatase depends on various factors such as the dosage form and mode of administration (lines 1-8, page 27) and Kiss teaches using 0.1-1 g alkaline phosphatase per m2 body surface for systemic administration, the recited dosage would have been found by one with ordinary skill in the art through routine experimentation and optimization.
Claim 20 is thus obvious over Furlan Freguia et al. in view of Kiss.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 17-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 7,790,685 in view of Furlan Freguia et al. (Pub. No. WO 2020/227263 A1).
US 7,790,685 is drawn to a method for stimulating proliferation and promoting survival of transplanted mesenchymal or hematopoietic stem cells and/or progenitor cells that take residency in bone marrow of a mammal needing regeneration of one or more normal tissues, the method including administering to said mammal a composition comprising placental alkaline phosphatase to stimulate proliferation and promote survival of the transplanted mesenchymal or hematopoietic cells. The placental alkaline phosphatase can be a recombinant protein. It can amount to about 0.01-2 gram per square meter of calculated surface area for the mammal.
The administering step comprises injecting into the mammal a suspension of the composition and a physiologically acceptable carrier, wherein the injection method can be intravenous, intraarterial, intraperitoneal, intramuscular, intraportal, subcutaneous, intradermal, direct injection into the target tissue, or involves a minipump inserted subcutaneously allowing controlled release of proteins. In an embodiment, the composition is administered before administering the transplanted cells.
Although the claims at issue are not identical, they are not patentably distinct from each other because in one embodiment, the administration of the composition is preceded by high dose chemotherapy, suggesting that the mammal is a cancer patient. And as discussed above, Furlan Freguia et al. teaches that a subject on chemotherapy experiences at least one side effect including anemia and myelosuppression, which reduces the level of red blood cells, white blood cells, and/or platelets. The at least one side effect can be treated or prevented by alkaline phosphatase like placental alkaline phosphatase, wherein said alkaline phosphatase can be recombinant or modified. Accordingly, it would have been obvious to perform the U.S. patent’s method to a cancer patient on chemotherapy and predict that it would treat or prevent a side effect such as anemia and myelosuppression.
Claims 17-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of co-pending Application No. 18/270349 in view of Kiss (Pub. No. US 2010/0279411 A1).
The co-pending application is directed to a method of administering human placental alkaline phosphatase or an active derivative thereof to a cancer patient without cachexia during chemotherapy. The human alkaline phosphatase can be isolated and highly purified from human placenta, or a recombinant protein, produced by a mammalian cell, a bacterium, a yeast, or purified from cow's milk, goat's milk, chicken egg, or a plant.
The placental alkaline phosphatase or an active derivative thereof is administered in therapeutically effective amounts in a range of between 0.005 to 2.5 g per m2, or between 0.05 to 1 g per m2, or between 0.1 to 1 g per m2 of the calculated body surface of the cancer patient. It can be administered to the cancer patient via infusion, a controlled release device, or injection (which can be intravenous, intra-arterial, intraperitoneal, intramuscular, intraportal, subcutaneous, or intradermal) in a physiologically acceptable carrier such as 0.9% sodium chloride solution, liposomes, immune liposomes, nanoparticles, or any other suitable carrier, three times a week, twice a week, once a week, or once every 10 days.
The claims at issue are not identical but they are not patentably distinct from each other because they entail administering human placental alkaline phosphatase to the same patient population (i.e., a cancer patient on chemotherapy). Moreover, Kiss teaches that placental alkaline phosphatase promotes survival and proliferation of stem cells before, during, and after transplantation, as well as regeneration of bone marrow (par. [0026], [0076]-[0081]). A person with ordinary skill in the art would have administered placental alkaline phosphatase to the cancer patient, followed by stem cells, with reasonable expectation that such modification would promote increasing the viability of stem cells and formation of blood cells.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651