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
Applicant’s election of the invention of Group I, claims 278-305, in the reply filed on 04/20/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant's election with traverse of the species of SEQ ID NO: 15 in the reply filed on 04/20/2026 is acknowledged. The traversal is on the ground(s) that also searching SEQ ID NOs: 2, 13, and 14 along with the elected sequence would not represent an undue burden of search. This argument is not found persuasive because the genus does not consist of SEQ ID NOs: 2 and 13-15 but, rather, all ENPP1 polypeptides, as recited in instant claim 1. Searching every possible ENPP1 polypeptide would certainly constitute an undue burden of search on the Examiner.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The 21-page information disclosure statement filed in this application on 06/17/2024 has been received and considered.
Claim Status
The response of 04/20/2026 has been entered. Claims 278-306 and 308-312 are pending in this US patent application. Claims 306 and 308-312 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/20/2026. Claims 294-296 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/20/2026.
Claims 278-293 and 297-305 are currently under examination and were examined on their merits.
Claim Interpretation
The elected claims are drawn to a lyophilized composition. Several of the claims (279-280, 291-292, 300-304) recite method steps or properties that the composition would have following the performance of a method step. A method step cannot limit a claimed composition. As such, any claim that recites a method step or properties that a composition would have after a method step is performed with the composition will be interpreted as equivalent to the claim from which it depends.
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 278-293 and 297-305 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.
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, claim 278 recites the broad recitation “a buffering agent,” and the claim also recites “succinate, citrate, bicarbonate, tris, or glycylglycine,” which is the narrower statement of the range/limitation. The claim(s) are 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 282 recites the formulation of claim 281, “wherein the one or more pharmaceutically acceptable additive comprises stabilizing agents, amino acids, salts, metal ions, and surfactants,” the grammar of which indicates that all of these types of ingredients must be present in the pharmaceutically acceptable additive. However, the claims which depend from claim 282 refer to the pharmaceutically acceptable additive as containing only one of those types of ingredients. For example, claim 283 recites the formulation of claim 282, wherein the pharmaceutically acceptable additive “is a sugar,” whereas claim 284 recites wherein the pharmaceutically acceptable additive “is an amino acid.” As such, one of ordinary skill in the art would be unable to determine whether the additive of claim 282 contains stabilizing agents, amino acids, salts, metal ions, and surfactants, as recited, or whether the additive of claim 282 is selected from the group consisting of stabilizing agents, amino acids, salts, metal ions, and surfactants, as is implied by the dependent claims.
Claims 297-298 recite functional characteristics of the buffering agent (claim 297) and pharmaceutical additive (claim 298) of the claims from which they depend. These limitations can be interpreted in two distinct ways. In the first interpretation, the recited functional characteristics of claims 297 and 298 represent inherent properties of the compositions of claims 278 and 282, respectively. In the second interpretation, claims 297-298 intend to structurally limit the compositions of claims 278 and 282, respectively, to particular subsets of buffering agent and pharmaceutical additive that produce the recited functions. The second interpretation is complicated by the lack of a conjunction in part (iv) of claim 297 and part (ii) of claim 298, which introduces confusion because it is unclear which of the recited percentages is intended to be required by the claim. As such, one of ordinary skill in the art would be unable to determine the metes and bounds of claims 297-298.
Because claims 279-293 and 297-305 depend from the indefinite claim 278 but provide no further clarification of the indefinite language therein, these claims are also indefinite. Therefore, claims 278-293 and 297-305 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted claim 278 to recite a lyophilized polypeptide formulation, wherein the formulation comprises: (a) an ENPP1 polypeptide, and (b) one or more of succinate, citrate, bicarbonate, tris, glycylglycine, a stabilizing agent, a salt, and a surfactant. The Examiner has interpreted claim 282 to recite that the additive is selected from the group consisting of stabilizing agents, amino acids, salts, metal ions, and surfactants. The Examiner has interpreted claims 297-298 to recite inherent functional properties of the compositions of the claims from which they depend. As such, any prior art that reads on the compositions of claims 278 and 282 will also be interpreted to read on claims 297 and 298, respectively.
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.
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.
Claims 278-293 and 297-305 are rejected under 35 U.S.C. 103 as being unpatentable over international patent application publication WO 2011/113027 filed by Quinn et al., published 09/15/2011, in view of US patent application publication 2014/0314745 filed by Rives et al., published 10/23/2014.
Quinn teaches fusion proteins comprising ENPP1 domains (see entire document, including page 1, lines 9-10, and page 2, lines 8-9). Claim 8 of Quinn recites a polypeptide comprising amino acids 99-925 of Quinn’s SEQ ID NO: 1, and this fragment is 100% identical to instant SEQ ID NO: 15, as shown in the alignment below (cf. claims 278 and 293). The polypeptide composition may contain pharmaceutically acceptable carriers and excipients and may be lyophilized (page 15, line 15, to page 16, line 2; cf. claim 278).
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However, Quinn does not teach that the carriers and excipients in the lyophilized composition are those recited in the instant claims.
Rives teaches methods of recombinantly producing proteins of interest (see entire document, including paragraph 0077). The protein of interest may be an enzyme (paragraph 0083). The proteins may be lyophilized in a composition containing acceptable carriers, excipients, and stabilizers, which may include glycine, citrate, sucrose, mannitol, sodium chloride, calcium chloride, and polysorbate 20 at desired concentrations (paragraphs 0173-0174; cf. claims 278-287, 289-292, and 297-305; the Examiner notes that making solutions of the ingredients taught by Rives, including sodium chloride, citrate, and calcium chloride, and then lyophilizing them as taught by Rives would result in the production of compositions that are structurally identical to those containing “tricitrate sodium dihydrate” and “calcium chloride dihydrate” as recited in claims 299-300). The pH of the composition may be about 6.2, about 6.3, about 6.4, or about 6.5 (paragraph 0175; cf. claim 288).
While Quinn does not teach that the pharmaceutically acceptable carriers and excipients contained in the lyophilized ENPP1 formulation are glycine, citrate, sucrose, mannitol, sodium chloride, calcium chloride, and polysorbate 20, it would have been obvious to one of ordinary skill in the art to include these compounds in the formulation of Quinn because Rives teaches that they are acceptable carriers, excipients, and stabilizers to include in lyophilized formulations of proteins, which may be enzymes. One of ordinary skill in the art would have a reasonable expectation that including the carriers, excipients, and stabilizers of Rives in the lyophilized formulation of Quinn would successfully result in the stabilization of Quinn’s lyophilized ENPP1 polypeptide to at least some degree.
Quinn and Rives do not teach the amounts of the formulation ingredients recited in instant claims 289 and 300-305. However, the instantly recited amounts would be within the realm of routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 part II A. It would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of all of the components in the lyophilized ENPP1 formulation because the concentrations of the components in an enzyme composition are art-recognized, result-effective variables known to affect the activity and stability of the enzyme, which would have been optimized in the art to provide the desired activity and stability.
Therefore, claims 278-293 and 297-305 are rendered obvious by Quinn in view of Rives and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by 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.
Claims 278-293 and 297-305 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12698487 in view of international patent application publication WO 2011/113027 filed by Quinn et al., published 09/15/2011, and US patent application publication 2014/0314745 filed by Rives et al., published 10/23/2014. The claims of ‘487 recite an ENPP1 formulation but do not recite that the formulation is lyophilized or contains the specific non-ENPP1 ingredients recited in the instant claims. However, the lyophilization of ENPP1 formulations and the inclusion of the instantly recited ingredients in said formulations are obvious over the teachings of Quinn and Rives, as discussed extensively above. As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘487 in view of Quinn and Rives and are rejected on the ground of nonstatutory double patenting.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Tuesday-Thursday, 6:30-4:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 09/24/2026
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