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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 29, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 – 17 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.
Claims 1 and its dependents are drawn to a method of administering a human placental alkaline phosphatase (hPLAP) “during chemotherapy,” where at least claims 1 – 5, 8 – 9, 15 and 17 recite the phrase. The phrase renders the claims indefinite as it is unclear how “during chemotherapy” intends to limit the method. Specifically, it is unclear if the phrase requires the PLAP to be administered at the same time as a chemotherapy is administered, any time during the course of treatment, any time prior to expected chemotherapy treatment, as a follow-up to chemotherapy, or any of these instances. Moreover, the scope of the claim is not clearly delineated by the phrase.
In claims 2 – 17, “the method” lacks proper antecedent basis.
In claim 2, the phrase “partially prevent” is not adequately defined by the claim language or specification such that one practicing the method would know what must occur to meet the limitation of the claim.
In claim 7, line 3, the phrase “is used” renders the claim indefinite as the phrase fails to positively state an active step that must be carried out to meet the method. Applicant may overcome this rejection by replacing “used” with “administered.”
In claim 11, the term “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 14 recites the broad recitation “0.005 – 2.5 g per m2,” and the claim also recites “0.05 – 1 g per m2” and “0.1 – 1 g per m2” which are narrower statements of the range/limitation. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1 – 12 and 14 – 16 are rejected under 35 U.S.C. 102a1 as being anticipated by Kiss (US 7695714 AND US 2007/0148155, IDS 06.29.2023 USPAB #2, both cited by 2007/0148155).
Regarding claim 1, Kiss teaches methods of administering human placental alkaline phosphatase (PLAP) to subjects with cancer (cancer patients), to enhance muscle protein synthesis reduce loss of muscle mass (muscle proteins) caused by cancer or chemotherapy (abstract).
Regarding claims 2 – 4, Kiss does not indicate the method accomplishes the recited intended functions or outcomes as a result of administering the PLAP. However, the methods are administering the same composition to the same treating population to achieve the same effect of increasing muscle protein synthesis/reduce or prevent loss of muscle proteins. Thus, the claimed function must be inherent to the reference method. The discovery of a previously unappreciated property of a prior art method, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new. Thus, the claiming of a new functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
Regarding claim 5, Kiss teaches the method prolongs the life of cancer patients (0026), or increases life expectancy.
Regarding claim 6, the hPLAP is isolated and highly purified (0015, examples 13, 16).
Regarding claim 7, Kiss teaches PLAP derivatives can be administered, such as those with a “smaller” sequence of peptides or those obtained by chemical synthesis (0028-0029, 0032).
Regarding claims 8 – 10, Kiss teaches the PLAP may be recombinantly made by methods disclosed by Kozlenkov, et al.(2002) (0033, example 2) which is incorporated by reference. Since the instant application obtains recombinant PLAP by the same exact methods (instant specification, example 2), the recombinant PLAP are interpreted as the same.
Regarding claim 11, the PLAP is administered via injection with a carrier such as physiological saline (sodium chloride) at 0.9%, liposomes or immunoliposomes (0041), once, twice or three times a week (0043).
Regarding claims 12 and 15, injection (systemic) may be intravenous, intraarterial, intramuscular, intraperitoneal, intraportal, intradermal or subcutaneous (0040).
Regarding claim 14, Kiss teaches the therapeutically effective amount of PALP is between about 0.01 to 2.5 g of alkaline phosphatase per m2 body surface of the mammal or between 0.1 to 1 g per m2 body surface of the subject (0042).
Regarding claim 16, the method further includes administering enhancers such as insulin-like growth factor I (0046).
The reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
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 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, 11, 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kiss (US 7695714 OR US 2007/0148155, IDS 06.29.2023 USPAB #2, both cited by 2007/0148155) in view of Kiss (2013/0251701, IDS 06.29.2023 USPAD #4)
Regarding claim 1, Kiss ‘155 teaches methods of administering human placental alkaline phosphatase (PLAP) to subjects with cancer (cancer patients), to enhance muscle protein synthesis reduce loss of muscle mass (muscle proteins) caused by cancer or chemotherapy (abstract).
Regarding claim 11, the PLAP is administered via injection with a carrier such as physiological saline (sodium chloride) at 0.9%, liposomes or immunoliposomes (0041), once, twice or three times a week (0043).
Regarding claims 13 and 17, Kiss ‘155 does not teach the method wherein the PLAP is administered via infusion, controlled release device, or continuously as needed. However, Kiss ‘155 teaches the PLAP can be administered by a variety of methods with delivery systems known in the art (0040 – 0041) and that the regimen can be optimized according to the patient’s weight and existing regimen (0042 – 0043). At the time the claims were filed, infusion and controlled release devices were known methods and delivery systems in the art for administering PLAP. In support, Kiss ‘701 teaches administering PLAP by infusion or with devices such as osmotic minipumps for providing controlled release of the PLAP (0038), wherein the PLAP is provided in the same carriers and amounts as claimed by applicant (0038). Thus, at the time the claims were filed, in practicing the methods of Kiss ‘155, it would have been obvious to one of ordinary skill in the art to administer the PLAP via infusion and/or controlled release device and optimize the frequency of release (e.g. continuously as needed) as a matter of routine practice in the art as demonstrated by Kiss ‘701 and with a reasonable expectation for successfully reducing/preventing muscle proteins.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
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.
Claim 1 – 15 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17 – 29 of copending Application No. 18/227 214 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of administering the same PLAP to the same treating population (e.g., as subject with cancer) in the same amounts and modes of administration, for the same purpose of decreasing loss of muscle mass, or proteins. Regarding the instantly claimed intended functions or outcomes as a result of administering the PLAP, the methods are administering the same composition to the same treating population to achieve the same effect of increasing muscle protein synthesis/reduce or prevent loss of muscle proteins. Thus, the claimed function must be inherent to the reference method. The discovery of a previously unappreciated property of a prior art method, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new. Thus, the claiming of a new functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 12 and 14 – 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 17 of U.S. Patent No. 7695714. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of administering the same PLAP to the same treating population (e.g., a subject with cancer) in the same amounts and modes of administration, for the same purpose of decreasing loss of muscle mass, or proteins. Regarding the instantly claimed intended functions or outcomes as a result of administering the PLAP, the methods are administering the same composition to the same treating population to achieve the same effect of increasing muscle protein synthesis/reduce or prevent loss of muscle proteins. Thus, the claimed function must be inherent to the reference method. The discovery of a previously unappreciated property of a prior art method, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new. Thus, the claiming of a new functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
Claims 1 – 7, 11 – 12, 14 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 – 9, 12 – 14 of U.S. Patent No. 7718170. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of administering the same PLAP to the same treating population (e.g., a subject with cancer) in the same amounts and modes of administration, for the same purpose of decreasing loss of muscle mass, or proteins. Regarding the instantly claimed intended functions or outcomes as a result of administering the PLAP, the methods are administering the same composition to the same treating population to achieve the same effect of increasing muscle protein synthesis/reduce or prevent loss of muscle proteins. Thus, the claimed function must be inherent to the reference method. The discovery of a previously unappreciated property of a prior art method, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new. Thus, the claiming of a new functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112)
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699