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 .
Response to Arguments
The Applicant has provided a response, dated 1/15/2026. In the response, the Applicant has included Information Disclosure Sheets (IDS), amended drawings, amendments to the claims (including the addition of claims 85-90, and the integration of dependent claim limitations into the independent claim), and arguments directed towards the previous rejections. The provided IDS has been considered. The provided drawings have allowed for a withdrawal of the objection to the drawings. The Applicant’s Arguments, and the amendments will be discussed in the following paragraphs and updated rejections.
On pages 9 and 10 of the Applicant’s Arguments, the Applicant asserts that Do cannot anticipate the claimed limitation, because Do’s range does not provide specific examples that fall within that range. The cited section of the MPEP indicates that all determinations of sufficient disclosure are determined on a case-by-case basis, and there is no one answer to this question. When considering “sufficient specificity,” the MPEP states:
If the claims are directed to a narrow range, and the reference teaches a broader range, other facts of the case, must be considered when determining whether the narrow range is disclosed with "sufficient specificity" to constitute an anticipation of the claims. Compare ClearValue Inc. v. Pearl River Polymers Inc., 668 F.3d 1340, 101 USPQ2d 1773 (Fed. Cir. 2012) with Atofina v. Great Lakes Chem. Corp, 441 F.3d 991, 999, 78 USPQ2d 1417, 1423 (Fed. Cir. 2006). See MPEP 2131.03(II).
However, the instant claim-set does not have a narrower range, it has an overlapping range that is just as large as Do’s, wherein Do provides for a 50% (30-80%) range and the instant claim-set provides for a 45% (55%-100%) range. It should be noted that the claimed range and Do’s range overlap in the range of 55-80%, which accounts for the majority of the claimed range. Furthermore, it should also be noted that an FVC value of 80% is the greatest value found in the Applicant’s data; this would suggest that Do explicitly anticipates the range of the Applicant’s applied and enabled data. Finally, the same section of the MPEP states:
In holding the claim anticipated, the court observed that "there is no allegation of criticality or any evidence demonstrating any difference across the range." Id. at 1345, 101 USPQ2d at 1777.
If the prior art disclosure does not disclose a claimed range with "sufficient specificity" to anticipate a claimed invention, any evidence of unexpected results within the narrow range may render the claims nonobvious. See MPEP § 716.02 et seq. The question of "sufficient specificity" is similar to that of "clearly envisaging" a species from a generic teaching. See MPEP § 2131.02.
The Applicant has never suggested that the claimed range provides for any amount of criticality to suggest that the specific range would not be anticipated over Do, and there is no evidence provided to suggest any unexpected results. It should also be noted that the range discloses a subject pool, and is not related to any methods of treating; there is nothing to suggest that this subject pool would provide for any unexpected results that the rest of the subject pool would not obtain.
On pages 10 and 11 of the Applicant’s Arguments, the Applicant asserts that the non-statutory double patenting rejections should be withdrawn because the cited patents do not disclose the claimed patient population with sufficient specificity. When looking at the patent limitations, the claims are drawn to Pompe disease, and do not provide any limitations on the specific subject pool. This would suggest that the patented claims would include the claimed subject pool and those that are not in the claimed subject pool. Since the claimed subject pool is entirely encompassed by the patent’s limitation, performing the method of the patent would directly read upon all embodiments provided in the instant claim-set. As discussed above, unless the claimed range provides for some form of unexpected outcome, and is thusly critical, the patent continues to read upon the instant application.
The Applicant’s amendment to the claims has required the wording of the rejections to be modified. However, the prior rejections are maintained for all of the reasons set forth previously.
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 1-3, 5, 7-11, 14, 18, 19, 22, 25, 26, 29 and 85-90 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Do, et al (WO 2018/213340A1). Do teaches a method of treating Pompe Disease with recombinanat human acid α-glucosidase (rhGAA), and miglustat, which is defined as a “chaperone.” See paragraph [003] [013]. Do indicates that the rhGAA molecules used have 7 potential N-glycosylation sites; Do indicates that the rhGAA has the same type and number as the claimed complex N-glycan percent and states that there is the same mole-value of bis-mannose-6-phosphate present on the rhGAA. Do states that the cited values can be provided by using liquid chromatograph-tandem mass spectrometry. See paragraph [011] [073]. Do states that the method results in an improvement of Pompe disease-related pathologies. See paragraph [009]. Do states that the subject pool includes individuals with an FVC score between 30-80%, which necessarily includes the claimed “greater than or equal to 55%.” See paragraph [0224]. Since there is no suggestion that the claimed range is critical, this assessment of anticipation is reasonable.
With respect to claims 1, 89 and 90, Do teaches the same method as that claimed, wherein Do explicitly describes an FVC range that includes the limitations of claims 89 and 90.
With respect to claims 2, 3, and 5, Do teaches the same improvements in the 6-minute walk test (6MWT). See paragraph [017]. However, even if Do does not provide for the explicitly claimed improvement, Do entirely anticipates the claimed method. As such, all results must necessarily be inherent to the claimed method, and present in the method of Do. See MPEP 2112(I) and 2112(II).
With respect to claims 7 and 8, Do appears to provide data for those with both above and below 300-meter baseline 6MWT. See figure 24B.
With respect to claims 9-11 and 14, Do teaches the forced vital capacity (FVC) test, and appears to indicate the same claimed improvements. See paragraph [021]. However, even if Do does not provide for the explicitly claimed improvement, Do entirely anticipates the claimed method. As such, all results must necessarily be inherent to the claimed.
With respect to claims 18, 19 and 22, Do teaches the gait, stair, gower, chair (GSGC) test, and provides for the same improvement. See paragraph [017]. However, even if Do does not provide for the explicitly claimed improvement, Do entirely anticipates the claimed method. As such, all results must necessarily be inherent to the claimed. See MPEP 2112(I) and 2112(II).
With respect to claims 25, 26 and 29, Do teaches the same improvements in creatine kinase and urine hexose tetrasaccharide levels. See paragraph [016] [023]. However, even if Do does not provide for the explicitly claimed improvement, Do entirely anticipates the claimed method. As such, all results must necessarily be inherent to the claimed. See MPEP 2112(I) and 2112(II).
With respect to claims 85 and 86, Do teaches 20 mg/kg of rhGAA administered intravenously, and 50-260 mg of the chaperone administered orally. See paragraph [0175].
With respect to claim 87, Do teaches that the chaperone can be miglustat. See paragraph [0175].
With respect to claim 88, Do indicates that the subject should fast for the two hours before and after miglustat administration. See paragraph [0181].
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 1-3, 5, 7-11, 14, 18, 19, 22, 25, 26, 29 and 85-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims1-19 of U.S. Patent No. 12,246,062. Although the claims at issue are not identical, they are not patentably distinct from each other because the two inventions provide for inventions with overlapping scope, wherein the patent provides for a slightly narrower invention than that claimed in the instant claim set.
The patent provides for a method of treating symptoms associated with Pompe Disease, by administering rhGAA with the same glycosylation, the same presence of M6P residues, and the same presence of the chaperone: miglustat. The patent provides for a specifically claimed dosage to achieve the claimed treatment, and also limits the subject-pool to ERT-switch patients, which appear to be consistent with ERT-experienced patients.
The instant claims provide for a method of treating Pompe Disease by administering the same rhGAA, and a chaperone that could include miglustat, but is not limited to miglustat. The instant invention provides for dependent claims the disclose the same symptom improvements as those disclosed in the independent claims of the patent. The independent claim of the instant patent does not limit the subject-pool to ERT-experienced patients, and can include ERT-naïve patients as well. Based upon this assessment, the claimed patent would anticipate the claims of the instant invention. As such, the instant application must be considered statutory double patenting with the cited patent.
Claims 1-3, 5, 7-11, 14, 18, 19, 22, 25, 26, 29 and 85-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,278,601. Although the claims at issue are not identical, they are not patentably distinct from each other because the two inventions provide for inventions with overlapping scope.
The patent provides for a method of treating Pompe Disease by administering miglustat and a form of rhGAA with seven N-glycosylation sites and the presence of M6P. The patent provides for a specific dosing limitation.
The instant claims provide for a method of treating Pompe Disease by administering the same rhGAA, and a chaperone that could include miglustat, but is not limited to miglustat. The instant claims also provide for overlapping dosages. Based upon this assessment, the claimed patent would anticipate the claims of the instant invention. As such, the instant application must be considered statutory double patenting with the cited patent.
Claim 1-3, 5, 7-11, 14, 18, 19, 22, 25, 26, 29 and 85-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-75 of copending Application No. 18/943,360 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application provides for a method that possesses overlapping scope as the instant claims.
The copending application (referred herein as ‘360) provides for several independent claims that include methods of treating Pompe Disease, and symptoms thereof, with a form of rhGAA with seven N-glycosylation sites and the presence of M6P. Later dependent claims provide for the further inclusion of chaperones like miglustat (claims 54 and 55). Since the instant claim-set teaches the same treatment of Pompe with the same rhGAA, the instant claim-set must anticipate the method of ‘360. As such, the instant claims are provisionally rejected as being non-statutory double patenting with ‘360.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651