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
Claims 1-12 are pending in the instant application.
Election/Restrictions
Applicant elected without traverse Group 2 (claims 6-9) drawn to a method of use and without traverse K72 (72 repeats) in the response filed August 26, 2026.
The restriction is deemed proper and is made FINAL in this office action.
Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim.
Claims 6-12 are examined on the merits of this office action.
Sequence Compliance/Specification Objection
This application fails to comply with the requirements of 37 C.F.R 1.821-1.825 for the reasons set forth on the attached Notice to Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/or Amino Acid Sequence Disclosures. Applicant must comply with the requirements of the sequence rules (37 CFR 1.821-1.825) before the application can be examined under 35 U.S.C 131 and 132. Each sequence disclosed must appear separately in the “Sequence Listing.” Each sequence set forth in the “Sequence Listing” must be assigned a separate sequence identifier. The specification is objected to given applicant failed to include sequence identifiers in the specification for every instance of the sequence displayed (see pages 2-4…etc…).
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.
Claim 9 is 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 9 recites an “administration dose of the medicament” while depending from claim 7, which is directed to a method of preparing a medicament. It is unclear whether the recited administration dose limitation requires preparing a medication containing a particular amount of peptide, defines an individual dosage unit, or merely describes a dosage to be used during subsequent administration. Accordingly, the meets and bounds of claim preparation method are unclear because the claims does not distinctly identify how the recited 6 to 8.1 mass relationship limits the preparation method.
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.
Claim(s) 6-9, 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bidwell (WO2015051001).
Claim interpretation of claim 6: Under the broadest reasonable interpretation, claim 6 is directed to a method of preparing a medicament by incorporating the peptide of claim 1. The phrase “for neutralizing heparin” merely recites an intended use of the medicament and does not require an affirmative step of administering the medicament or neutralizing heparin. Accordingly, prior art disclosing incorporation of the claim peptide into a medicament would satisfy the claimed method, regardless of whether the prior are expressly discloses heparin neutralization, provided the medicament is suitable for the recited use.
Regarding claim 6, Bidwell discloses elastin like polypeptides (ELP) comprising tandem repeating units of the amino acid sequence VPGKG, corresponding to SEQ ID NO:1 of the instant application (see claims 22-27, claims 22-23 and SEQ ID Nos:11-12). Specifically, Bidwell discloses an ELP comprising About 40 repeating units of VPGXG, wherein X is lysine, thereby providing the identical repeating amino acid sequence VPGPG (claim 22). Bidwell further identifies the polypeptide comprising SEQ NO:11 (claim 23). Bidwell additionally discloses therapeutic compositions incorporating ELPs and pharmaceutical vehicles, carriers or excipients (see paragraph 0079) thus meeting the limitation of preparing a medicament. Regarding claim 11, Bidwell further discloses preparation and purification of ELPs, including re-solubilization of the polypeptides in PBS (see paragraph 0092). Regarding the phrase “for neutralizing heparin”, this langue is interpreted as reciting an intended use or purpose of the medicament rather than an affirmative step of the claimed preparation method. Claim 6 does not require administering the medicament, contacting the medicament with heparin, or actually neutralizing heparin. Nevertheless, Bidwell discloses the identical VPGKG repeating amino acid sequence. To the extent that the claimed heparin neutralizing capability is an inherent property of the disclosed peptide, such property would necessarily be possessed by the corresponding prior art peptide, regardless of whether Bidwell expressly recognizes its heparin neutralizing activity. The discovery of a previously unrecognized property of a known composition does not render the known composition patentably distinct (see MPEP 2112).
Regarding claim 7, claim 7 recites that the heparin comprises unfractionated heparin and/or low molecular weight heparin (LMWH). This limitation is interpreted as identifying the particular type of heparin intended to be neutralized by the prepared medicament. Claim 7 does not require incorporating unfractionated heparin or LMWH into the medicament, administering the medicament to a patient receiving either form of heparin, or performing an actual heparin neutralization step. Rather, the claimed preparation method remains directed to incorporating the heparin neutralizing peptide into a medicament. Thus, the recitation of unfractionated heparin and/or LMWH describes intended therapeutic application of the medicament and does not impose an additional manipulation on the claimed preparation method. Thus, the method of formulating the peptide into a medicament as taught by Bidwell meets the limitations of instant claim 7 and the peptide would inherently have the heparin neutralizing property.
Regarding claim 8, Bidwell discloses parenteral administration of ELP containing therapeutic compositions, including intravascular administration (see paragraph 0078). Furthermore, Bidwell discloses intravenous injection of labeled ELPS into rats at a dosage of 100 mg/kg (see paragraph 0094). Thus, Bidwell teaches IV administration of ELP containing preparations corresponding to the IV injection dosage form recited in instant claim 8.
Regarding claim 9, claim 9 depends on claim 7 and further recites that an administration dose of the medicament, based on the mass of the heparin neutralizing peptide, is 6-8 times the mass of heparin to be neutralized. Under the BRI consistent with the specification, this limitation describes a contemplated administration dosage rather than an affirmative step of the claimed method of preparing the medicament. Claim 9 does not require determining the mass of heparin to be neutralized calculating and administration dosage, administering the medicament, or incorporating a particular amount of peptide corresponding to a specified mass of heparin. Rather, the recited dosage relationship depends upon an unspecified amount of heparin involved in a potential subsequent administration. Accordingly, absent a more restrictive meaning established by the specification, the dosage relationship does not impose an additional preparation step or a particular formulation requirement and therefore does not distinguish an otherwise identical prior art preparation method. Thus, the method and formulation of Bidwell meets the limitations of instant claim 9.
Claim(s) 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (Adv. Mater. 2020, 32, 2000964, March 2020).
Claim interpretation of claim 6: Under the broadest reasonable interpretation, claim 6 is directed to a method of preparing a medicament by incorporating the peptide of claim 1. The phrase “for neutralizing heparin” merely recites an intended use of the medicament and does not require an affirmative step of administering the medicament or neutralizing heparin. Accordingly, prior art disclosing incorporation of the claim peptide into a medicament would satisfy the claimed method, regardless of whether the prior are expressly discloses heparin neutralization, provided the medicament is suitable for the recited use.
Regarding claims 6 and 10-11, Li discloses polypeptides comprising tandem repeating units of the amino acid sequence VPGKG, corresponding to SEQ ID NO:1 of the instant application (see Figure 1) and in PBS (see Figure 3, see page 5, right column). Specifically, Li discloses polypeptides comprising 72 repeats of instant SEQ ID NO:1 (Figure 1). Regarding instant claims 6 and 8, Li discloses incorporation of the peptide in a medicament for intravenous injection (see Figure 3).
Regarding the phrase “for neutralizing heparin”, this langue is interpreted as reciting an intended use or purpose of the medicament rather than an affirmative step of the claimed preparation method. Claim 6 does not require administering the medicament, contacting the medicament with heparin, or actually neutralizing heparin. Nevertheless, Li discloses the identical VPGKG repeating amino acid sequence. To the extent that the claimed heparin neutralizing capability is an inherent property of the disclosed peptide, such property would necessarily be possessed by the corresponding prior art peptide, regardless of whether Bidwell expressly recognizes its heparin neutralizing activity. The discovery of a previously unrecognized property of a known composition does not render the known composition patentably distinct (see MPEP 2112).
Regarding claim 7, claim 7 recites that the heparin comprises unfractionated heparin and/or low molecular weight heparin (LMWH). This limitation is interpreted as identifying the particular type of heparin intended to be neutralized by the prepared medicament. Claim 7 does not require incorporating unfractionated heparin or LMWH into the medicament, administering the medicament to a patient receiving either form of heparin, or performing an actual heparin neutralization step. Rather, the claimed preparation method remains directed to incorporating the heparin neutralizing peptide into a medicament. Thus, the recitation of unfractionated heparin and/or LMWH describes intended therapeutic application of the medicament and does not impose an additional manipulation on the claimed preparation method. Thus, the method of formulating the peptide into a medicament as taught by Li meets the limitations of instant claim 7 and the peptide would inherently have the heparin neutralizing property.
Regarding claim 9, claim 9 depends on claim 7 and further recites that an administration dose of the medicament, based on the mass of the heparin neutralizing peptide, is 6-8 times the mass of heparin to be neutralized. Under the BRI consistent with the specification, this limitation describes a contemplated administration dosage rather than an affirmative step of the claimed method of preparing the medicament. Claim 9 does not require determining the mass of heparin to be neutralized calculating and administration dosage, administering the medicament, or incorporating a particular amount of peptide corresponding to a specified mass of heparin. Rather, the recited dosage relationship depends upon an unspecified amount of heparin involved in a potential subsequent administration. Accordingly, absent a more restrictive meaning established by the specification, the dosage relationship does not impose an additional preparation step or a particular formulation requirement and therefore does not distinguish an otherwise identical prior art preparation method. Thus, the method and formulation of Li meets the limitations of instant claim 9.
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.
The factual inquiries 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.
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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bidwell (WO2015051001).
Regarding claim 6, Bidwell discloses elastin like polypeptides (ELP) comprising tandem repeating units of the amino acid sequence VPGKG, corresponding to SEQ ID NO:1 of the instant application (see claims 22-27, claims 22-23 and SEQ ID Nos:11-12). Specifically, Bidwell discloses an ELP comprising About 40 repeating units of VPGXG, wherein X is lysine, thereby providing the identical repeating amino acid sequence VPGPG (claim 22). Bidwell further identifies the polypeptide comprising SEQ NO:11 (claim 23). Bidwell additionally discloses therapeutic compositions incorporating ELPs and pharmaceutical vehicles, carriers or excipients (see paragraph 0079) thus meeting the limitation of preparing a medicament. Regarding claim 11, Bidwell further discloses preparation and purification of ELPs, including re-solubilization of the polypeptides in PBS (see paragraph 0092). Regarding the phrase “for neutralizing heparin”, this langue is interpreted as reciting an intended use or purpose of the medicament rather than an affirmative step of the claimed preparation method. Claim 6 does not require administering the medicament, contacting the medicament with heparin, or actually neutralizing heparin. Nevertheless, Bidwell discloses the identical VPGKG repeating amino acid sequence. To the extent that the claimed heparin neutralizing capability is an inherent property of the disclosed peptide, such property would necessarily be possessed by the corresponding prior art peptide, regardless of whether Bidwell expressly recognizes its heparin neutralizing activity. The discovery of a previously unrecognized property of a known composition does not render the known composition patentably distinct (see MPEP 2112).
Regarding claim 7, claim 7 recites that the heparin comprises unfractionated heparin and/or low molecular weight heparin (LMWH). This limitation is interpreted as identifying the particular type of heparin intended to be neutralized by the prepared medicament. Claim 7 does not require incorporating unfractionated heparin or LMWH into the medicament, administering the medicament to a patient receiving either form of heparin, or performing an actual heparin neutralization step. Rather, the claimed preparation method remains directed to incorporating the heparin neutralizing peptide into a medicament. Thus, the recitation of unfractionated heparin and/or LMWH describes intended therapeutic application of the medicament and does not impose an additional manipulation on the claimed preparation method. Thus, the method of formulating the peptide into a medicament as taught by Bidwell meets the limitations of instant claim 7 and the peptide would inherently have the heparin neutralizing property.
Regarding claim 8, Bidwell discloses parenteral administration of ELP containing therapeutic compositions, including intravascular administration (see paragraph 0078). Furthermore, Bidwell discloses intravenous injection of labeled ELPS into rats at a dosage of 100 mg/kg (see paragraph 0094). Thus, Bidwell teaches IV administration of ELP containing preparations corresponding to the IV injection dosage form recited in instant claim 8.
Regarding claim 9, claim 9 depends on claim 7 and further recites that an administration dose of the medicament, based on the mass of the heparin neutralizing peptide, is 6-8 times the mass of heparin to be neutralized. Under the BRI consistent with the specification, this limitation describes a contemplated administration dosage rather than an affirmative step of the claimed method of preparing the medicament. Claim 9 does not require determining the mass of heparin to be neutralized calculating and administration dosage, administering the medicament, or incorporating a particular amount of peptide corresponding to a specified mass of heparin. Rather, the recited dosage relationship depends upon an unspecified amount of heparin involved in a potential subsequent administration. Accordingly, absent a more restrictive meaning established by the specification, the dosage relationship does not impose an additional preparation step or a particular formulation requirement and therefore does not distinguish an otherwise identical prior art preparation method. Thus, the method and formulation of Bidwell meets the limitations of instant claim 9.
Bidwell does not expressly disclose that the concentration of the VPGKG containing peptide is the medicament is 5-200 ug/mL as recited in instant claim 12.
However, Bidwell teaches that ELP dosage may be adjusted according to the formulation and route of administration (see paragraph 0079). Bidwell further reports steady state plasma concentrations of approximately 33.94 microgram per mL for ELP and 69 microgram per mL for ELP fusions (see Example 3; figure 7A), Demonstrating the concentrations numerically within the claim range were noting connection with ELP therapeutic delivery. It would have been obvious before the effective filing date of the claim invention to adjust the concentration of ELP in Bidwell’s pharmaceutical composition to obtain a desired therapeutic exposure, including through routine optimization, with a reasonable expectation of achieving an appropriate dosage for administration (2144.05).
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 6-7, 9-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 9334312 in view of Sharma (US20150098908 A1, cited in Applicant’s IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims A method of preparing a medicament for neutralizing heparin comprising incorporating the heparin neutralizing peptide according to claim 1 which is a peptide comprising tandem repeats of SEQ ID NO:1 (VPGKG). The instant application further claims where it is for IV injection (claim 8); 18, 36, 72, 144 repeats (claim 10); PBS (claim 11); 5-200 ug/ml (claim 12).
US Patent No. 9334312 claims “A branched proteinaceous biolubricant substance having a degree n of branching, wherein each of the branches comprises the amino acid sequence (SEQ ID NO: 1)m, and wherein n times m is at least 40” (claim 7). SEQ ID NO:1 is GKGVP which repeated 40 times comprises 39 repeats of instant SEQ ID NO:1. US Patent No. 9334312 claims administering the peptide as a medicament (see claim 29). US Patent No. 9334312 is silent to use in saline, the specific concentration and the specific number of repeats but does teach repeat anywhere from 1-50 (claims 17, for example) . However, US20150098908 A1 teaches the same peptides in combination with saline (see paragraph 0037). Sharma also teaches “Typically, the value of n is up to 30, preferably up to 20. In one embodiment, n is an integer in the range of 5-20, like 6-18 or 8-14”. Thus, the number of repeats is clearly a result effective variable and it would have been obvious to optimize the number to achieve optimal therapeutic effectiveness. Regarding the concentration, Sharma teaches dosing (claim 0028) and 0.05% w/v of the peptide. However, it would have been obvious to optimize the concentration to achieve optimal therapeutic effectiveness and ease for administering the desired dose.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/Primary Examiner, Art Unit 1654
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