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 .
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (page 28). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The specification is also objected to because it does not included a Brief Description of the Drawings section. Note the required contents of the specification:
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
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 33 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.
Given that patients have previously generated antibodies to FVIII (independent claim 23, the claim from which claim 33 immediately depends), it is unclear how a composition comprising FVIII could be administered separately or subsequently to the composition of claim 33. Indeed the whole point of the instant invention is to shield FVIII from the patient’s immune system, without affecting its activity in the coagulation cascade, by utilizing the colloidal particle of claim 23. How then could a composition of FVIII be efficaciously administered except with the colloidal particle (i.e. non-covalently bound of the surface – note the art cited in 103 rejections below).
Clarification is in order.
Claims 45, 47 and 48 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.
There is insufficient antecedent basis for the limitation “…the non-ionic surfactant…” in the claims.
The examiner respectfully suggests that the claims should properly depend from claim 31 (not claim 32).
Claims 49 and 50 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.
Claim 33, the claim from which each of claims 49 and 50 separately depend, explicitly teaches that a composition of Factor VIII is administered separately or subsequent to administration of the composition comprising the colloidal particle of independent claim 23. That being the case, it is unclear how the colloidal particle can comprise Factor VIII. If a composition comprising Factor VIII is administered separately or subsequent to administration of the colloidal particle of independent claim 23 (claim 33), it cannot have been a component of the composition comprising the colloidal particle in the first place (claims 49 and 50).
Clarification is in order.
Claim 46 is also 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.
The claim depends from an indefinite claim yet does not relieve the indefiniteness. Dependent claim 46 is also, therefore, indefinite.
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:
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 23-30, 34, 35, 43, 44, 51 and 52 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Haemophilia (2010), 16, pp. 910-918, cited in the IDS.
The reference teaches a method of treating haemophilia A, in patients with inhibitory antibodies to Factor VIII (FVIII), comprising administering an injectable solution of a PEGylated liposome (i.e. a colloidal particle) comprising a 97:3 molar ratio of 1-palmitoyl-2-oleoyl phosphatidylcholine (i.e. a first amphipathic lipid comprising a phosphatidylcholine (PC) moiety) to 1,2-distearoyl-sn-glycero-3-phosphatidylethanolamine-N[methoxy(polyethyeneglycol)-2000] (DSPE-PEG 2000) (i.e. a second amphipathic lipid comprising a phospholipid moiety selected from a phosphatidyl ethanolamine (PE), a phosphatidylserine (PS), and a phosphatidyl inositol (PI) and which is derivatized with a biocompatible hydrophilic polymer (i.e. PEG)) (abstract; p. 910, Introduction; p. 911, Subjects, Inclusion and exclusion criteria, Liposomes; p. 912, text line 1). The liposome formulation is utilized to deliver the therapeutically active compound Factor VIIa (FVIIa) (abstract).
Haemophilia (2010), 16, pp. 910-918 does not teach a detailed method for the preparation of the liposomes, but instead incorporates by reference an earlier paper (Thrombosis and Haemostasis (2005), 93, pp. 1061-1068) which details the preparation of the liposomes utilized in Haemophilia (2010), 16, pp. 910-918 (p. 911, Liposomes). That earlier paper, Thrombosis and Haemostasis (2005), 93, pp. 1061-1068, teaches that 1-palmitoyl-2-oleoyl phosphatidylcholine (POPC) and 1,2-distearoyl-sn-glycero-3-phosphatidylethanolamine-N[methoxy(polyethyeneglycol)-2000] (DSPE-PEG 2000) are first dissolved in tert-butanol and lyophilized and then the resulting dry powder resuspended in sodium citrate buffer to form liposomes (p. 1062, Materials and methods, Liposome preparation).
Claim 28 is included in this rejection because 1-palmitoyl-2-oleoyl phosphatidylcholine (Haemophilia (2010), 16, pp. 910-918) is the same compound as 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) (claim 28). Note also that Thrombosis and Haemostasis (2005), 93, pp. 1061-1068 teaches 1-palmitoyl-2-oleoyl phosphatidylcholine (POPC). All these names are synonyms for the same compound.
Claims 34 and 35 are included in this rejection because the inclusion criteria outlined in Haemophilia (2010), 16, pp. 910-918 (patients ≥16 years of age with ≤1% FVIII activity and inhibitory antibodies to FVIII (p. 911, Inclusion and exclusion criteria)) would intrinsically encompass a subset of all congenital haemophilia A patients, as well as a subset of all acquired haemophilia A patients.
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.
Claims 23-30, 32, 34-36, 43, 44 and 49-52 are rejected under 35 U.S.C. 103 as being unpatentable over Haemophilia (2010), 16, pp. 910-918, cited in the IDS, and further in view of Thrombosis and Haemostasis (2005), 93, pp. 1061-1068.
Inventor teaches a method of treating haemophilia A, in a subject who has previously developed antibodies to Factor VIII (FVIII), comprising administering a composition comprising a colloidal particle comprising (i) a first amphipathic lipid comprising a phosphatidylcholine (PC) moiety and (ii) a second amphipathic lipid comprising a phospholipid moiety, selected from a phosphatidyl ethanolamine (PE), a phosphatidylserine (PS), and a phosphatidyl inositol (PI), and which is derivatized with a biocompatible hydrophilic polymer (independent claim 23). Dependent claims 24-27 further define the biocompatible polymer. Claim 28 teaches that the first lipid is POPC. Dependent claim 29 teaches that the second lipid is DSPE-PEG. Dependent claim 30 further defines the DSPE-PEG. Dependent claim 32 teaches that the composition further comprises Factor VIII (FVIII). Dependent claims 34-36 further define the patient. Dependent claims 43 and 44 teach the ratio of the lipids. Dependent claims 49 and 50 teach the ratio of colloidal particle to FVIII. Dependent claim 51 (from claim 23) teaches that the colloidal particle further comprises a therapeutically active compound. Dependent claim 52 further defines the composition (i.e. contains an excipient, diluent or adjuvant).
Haemophilia (2010), 16, pp. 910-918 has been outlined above (102 rejection).
Thrombosis and Haemostasis (2005), 93, pp. 1061-1068, as outlined above (102 rejection), teaches that 1-palmitoyl-2-oleoyl phosphatidylcholine (POPC) and 1,2-distearoyl-sn-glycero-3-phosphatidylethanolamine-N[methoxy(polyethyeneglycol)-2000] (DSPE-PEG 2000) are first dissolved in tert-butanol and lyophilized and then the resulting dry powder resuspended in sodium citrate buffer to form liposomes (p. 1062, Materials and methods, Liposome preparation). The reference, utilizing a murine model, further teaches that this liposome is utilized in a method for treating inherited haemophilia A (abstract; Introduction). The liposome is formulated with recombinant Factor VIII (rFVIII) which binds non-covalently, but with high affinity, with the external surface of the liposome without affecting its subsequent activity (abstract; p. 1066, Discussion). Preparation method: liposome solution injected into an rFVIII concentrate vial at a ratio of 1 ml liposome dispersion to 100 units of FVIII (p. 1062, Formulation of FVIII and liposomes).
Inventor principally distinguishes over Haemophilia (2010), 16, pp. 910-918 in that rFVIII is utilized as the therapeutic agent (rather than the bypass agent FVIIa). However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to utilize rFVIII as the therapeutic agent, as taught by Thrombosis and Haemostasis (2005), 93, pp. 1061-1068, in the method of Haemophilia (2010), 16, pp. 910-918. This is so because FVIII is the compound that the haemophilia A patients actually lack. But because the patients have developed antibodies to FVIII, it cannot be utilized. However, Thrombosis and Haemostasis (2005), 93, pp. 1061-1068 teaches a method utilizing a rFVIII non-covalently bonded to the liposome such that it is shielded from the patient’s immune system and, furthermore, does not affect its normal participation in the coagulation cascade. One of ordinary skill would have been motivated, and with a reasonable expectation of success, to substitute the rFVIII-loaded liposome of Thrombosis and Haemostasis (2005), 93, pp. 1061-1068 for the FVIIa liposome of Haemophilia (2010), 16, pp. 910-918 - because doing so can directly deliver FVIII, thus avoiding the ‘work around’ bypass strategy of administering FVIIa.
Claim 28 is included in this rejection because 1-palmitoyl-2-oleoyl phosphatidylcholine (Haemophilia (2010), 16, pp. 910-918) is the same compound as 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) (claim 28). Note also that Thrombosis and Haemostasis (2005), 93, pp. 1061-1068 teaches 1-palmitoyl-2-oleoyl phosphatidylcholine (POPC). All these names are synonyms for the same compound.
Claims 34 and 35 are included in this rejection because the inclusion criteria outlined in Haemophilia (2010), 16, pp. 910-918 (patients ≥16 years of age with ≤1% FVIII activity and inhibitory antibodies to FVIII (p. 911, Inclusion and exclusion criteria)) would intrinsically encompass a subset of all congenital haemophilia A patients, as well as a subset of all acquired haemophilia A patients.
Claim 36 is included in this rejection because both references, although predicated upon either the adult patients of Haemophilia (2010), 16, pp. 910-918 or the murine model of Thrombosis and Haemostasis (2005), 93, pp. 1061-1068, are clearly intended as general and broadly applicable references. That being the case, one of ordinary skill would have understood that a pediatric haemophilia A patient who has previously generated antibodies to FVIII would be a suitable patient for the prior art therapy.
Claims 49 and 50 are included in this rejection because their imitation (ratio of colloidal particle to FVIII) is a results effective variable and one of ordinary skill (a highly skilled individual such as a clinical or laboratory physician), and absent unexpected results, would have found it obvious to extrapolate (from the prior art murine model) to a ratio suitable and efficacious for treating human haemophilia A patients with FVIII.
Claims 31 and 45-48 are rejected under 35 U.S.C. 103 as being unpatentable over Haemophilia (2010), 16, pp. 910-918, cited in the IDS, and further in view of International Journal of Cosmetic Science (1992), 14, pp. 131-149 and J. Mater. Sci.: Mater. Med. (2008), 19, pp. 607-614.
Inventor teaches a method of treating haemophilia A, in a subject who has previously developed antibodies to Factor VIII (FVIII), comprising administering a composition comprising a colloidal particle comprising (i) a first amphipathic lipid comprising a phosphatidylcholine (PC) moiety and (ii) a second amphipathic lipid comprising a phospholipid moiety, selected from a phosphatidyl ethanolamine (PE), a phosphatidylserine (PS), and a phosphatidyl inositol (PI), and which is derivatized with a biocompatible hydrophilic polymer and further comprising a non-ionic surfactant (claim 31). Dependent claims 45 (note the 112(b) rejection above) further defines the non-ionic surfactant (polyoxyethylene sorbitan, polyhydroxyethylene stearate, polyhydroxyethylene lauryl ether). Dependent claim 46 (note the 112(b) rejection above) further defines the polyoxyethylene sorbitan (polyoxyethylene (20) monooleate). Dependent claims 47 and 48 (note the 112(b) rejection above) teach ratios of the colloidal particle to the non-ionic surfactant.
Haemophilia (2010), 16, pp. 910-918 has been outlined above (102 rejection).
International Journal of Cosmetic Science (1992), 14, pp. 131-149 teaches the modification of liposome structures through interaction with surfactants (abstract).
J. Mater. Sci.: Mater. Med. (2008), 19, pp. 607-614 teaches the modification of PEGylated vesicles which comprise PEG2000-DSPE (i.e. DSPE-PEG2000) and the non-ionic surfactant Span® 40 (abstract). (Span® 40 is sorbitan monopalmitate.)
As evidenced by International Journal of Cosmetic Science (1992), 14, pp. 131-149, the modification of the physico-chemical properties of liposomes by surfactants has been known and exploited for a considerable period of time. J. Mater. Sci.: Mater. Med. (2008), 19, pp. 607-614 provides a specific example of this where a commercially available non-ionic surfactant (one of many) is used to modify the properties of a PEGylated vesicle.
Inventor principally distinguishes over the cited art in that a particular non-ionic surfactant, classes of surfactants, and their amounts (colloidal particle/surfactant ratio) are taught. However, as International Journal of Cosmetic Science (1992), 14, pp. 131-149 and J. Mater. Sci.: Mater. Med. (2008), 19, pp. 607-614 make clear, it is well-known in the relevant art that surfactants, and non-ionic surfactants in particular, are useful for the modification of the properties of liposomes, and in particular PEGylated vesicles. One of ordinary skill, before the effective filing date of the instant invention, would have found obvious the utilization of a non-ionic surfactant for the modification of the physico-chemical properties of liposomes – absent unexpected results. One of ordinary skill would have been motivated to do so, and with a reasonable expectation of success, in order to tailor, by the particular choice of surfactant and amount thereof, the physico-chemical properties of the liposome to any particular application, such as, for instance, drug delivery.
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 23, 31 and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/683,975 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The two applications teach the same method. In the instant application, the limitations are distributed over 3 nested claims (independent claim 23 and dependent claims 31 and 47 – note the 112(b) rejection above with respect to claim 47), while in the reference application this subject matter is incorporated into a single independent claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5 EST.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 11/9/2025