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 without traverse of Group III (claims 22, 24-25, 27-31 and 33-34) in the reply filed on 10/27/2025 is acknowledged.
Claims 2, 5, 8-9, 12-13, 15-16, 18-19, 21, 23, 26, 32 and 35-36 have been canceled, claims 1, 3-4, 6-7, 10-11, 14, 17, and 20 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 22, 24-25, 27-31 and 33-34 have been considered on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The priority claim based on the foreign document is granted and the earliest filing date of the instant application is determined as 8/10/2020.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22, 24-25, 27-31 and 33-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are directed to a method of “treating” a subject with ANY “inflammatory disease” by administering a composition of mesenchymal lineage precursor or stem cells.
The scope of “treating” is broad as the instant specification does not define the term but discloses examples of the term. Paragraph [0047] of the instant specification discloses: “the terms “treating”, “treat” or “treatment” include administering a population of mesenchymal lineage stem or precursor cells and/or progeny thereof and/or soluble factors derived therefrom to thereby reduce or eliminate at least one symptom of a disease disclosed herein.” This statement is not a definition limiting the scope of the term “treating” and thus, the scope of “treating” would encompass any outcome of the method including not only “reducing” at least one symptom of the inflammatory disease but also “preventing” or “curing” of any inflammatory disease. It is noted that “eliminating at least one symptom” would be broadly considered as “curing”, i.e. eliminating all the symptoms of an inflammatory disease.
The scope of “inflammatory disease” is extremely broad encompassing any infection to the GVHD as claimed in claim 25. The instant specification discloses examples of T-cell mediated inflammatory disease including IBD, UC and GVHD or hyperinflammation caused by viral infection. The T-cell mediated inflammatory diseases would also encompass autoimmune diseases.
Considering the broad scope of “treating” that encompassing “preventing” and “curing” as discussed above and the lack of description in the instant specification with regard to “preventing” or “curing” any inflammatory disease using the claimed cells, it is considered that the instant specification failed to provide sufficient written description to support the entire scope of the claimed invention.
The instant specification does not provide any convincing evidence that the claimed method would necessarily and sufficiently prevent or cure the GVHD or any inflammatory disease in a subject. The description in the instant specification is prophetic and no actual results to support the claimed method to arrive preventing or curing of any inflammatory disease including T-cell mediated inflammatory disease such as GVHD.
With the prophetic embodiment and limited description in the instant specification, and highly unpredictable nature of the claimed method particularly in preventing and/or curing the inflammatory disease including GVHD, it is the Examiner’s position that the inventors did not have possession on the entire scope of the claimed “treating” of the inflammatory disease using the claimed mesenchymal precursor or stem cells.
M.P.E.P. §2163 states “To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.”
M.P.E.P. § 2163 also recites, “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention… one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.” and further, “The description needed to satisfy the requirements of 35 U.S.C. 112 "varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084.< Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art. In most technologies which are mature, and wherein the knowledge and level of skill in the art is high, a written description question should not be raised for claims >present in the application when originally filed,< even if the specification discloses only a method of making the invention and the function of the invention. See, e.g., In re Hayes Microcomputer Products, Inc. Patent Litigation, 982 F.2d 1527, 1534-35, 25 USPQ2d 1241, 1246 (Fed. Cir. 1992) ("One skilled in the art would know how to program a microprocessor to perform the necessary steps described in the specification. Thus, an inventor is not required to describe every detail of his invention. An applicant's disclosure obligation varies according to the art to which the invention pertains. Disclosing a microprocessor capable of performing certain functions is sufficient to satisfy the requirement of section 112, first paragraph, when one skilled in the relevant art would understand what is intended and know how to carry it out."). In contrast, for inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession.”
Claims 22, 24-25, 27-31 and 33-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for reducing at least one symptoms of an inflammatory disease, does not reasonably provide enablement for preventing or curing the inflammatory disease including GVHD. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQd 1400, 1404 (Fed. Cir. 1988) (a) the breadth of the claims; (b) the nature of the invention; (c) the state of the prior art; (d) the level of one of ordinary skill; (e) the level of predictability in the art; (f) the amount of direction provided by the inventor; (g) the existence of working examples; and (h) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. While all of these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
The instant claims are directed to a method of treating an inflammatory disease in a subject comprising administering a composition comprising mesenchymal precursor or stem cells (MLPSCs) to the subject.
As discussed above, the scope of “treating” has been determined to encompass “preventing” or “curing” any inflammatory disease including GVHD.
While certain inflammatory disease might be preventable, however, it is understood that the inflammation is associated with the body’s immune system, and cannot get rid of the system unless the cause of the inflammation is prevented. For example, some viral infection or bacterial infection might not be prevented.
It is not known in the art that any inflammatory disease can be “cured” by any known means. Particularly, for GVHD, there is no known prevention or cure of this inflammatory disease. Thus, while inflammatory diseases can be treated to reduce, improve or ameliorate the symptoms by many known means including stem cell therapy, however, they cannot be successfully prevented or cured.
The instant specification does not provide any working example and the disclosure is merely prophetic without providing any evidence that the claimed method would produce the claimed “treating” or any therapeutically effective outcome. Considering the characteristic of the claimed cells possessing anti-inflammatory property as discussed in the instant specification, it is plausible that the claimed cells would provide some improvement in controlling the conditions of an inflammatory diseases. However, there is no showing in the instant specification such that the claimed cells would be able to prevent the onset of any inflammatory diseases or cure any inflammatory disease including GVHD.
M.P.E.P. § 2164.03 reads, "The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The 'amount of guidance or direction' refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. V. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) ("In applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required.”).”
The court has recognized that physiological activity is unpredictable. In re Fisher, 166 USPQ 18 (CCPA 1970). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved. In re Fisher, 166 USPQ 18 (CCPA 1970).
It is not to be left up to the skilled artisan to figure out how to make the necessary starting materials and then to figure out how to use them to produce the biological effects as recited in the claims. The courts held that the disclosure of an application shall inform those skilled in the art how to use applicant's claimed invention, not how to find out how to use it for themselves. In re Gardner et al. 166 USPQ 138 (CCPA 1970). For the broad scope of the claims, this specification only teaches what is intended to be done and how it is intended to work, but does not actually teach how to do that which is intended.
Thus, it is highly unpredictable if the claimed method would be able to prevent the onset of any inflammatory disease or cure the inflammatory disease in the subject. There is no working embodiment and no known data in the art suggesting that the prevention and/or cure of the inflammatory disease including GVHD is possible. Thus, there is undue experimentations needed to be carried out to determine if the claimed method would enable a person skilled in the art to successfully prevent and/or cure the GVHD or any other inflammatory disease for that matter.
Applicant is advised to amend the term “treating a subject with an inflammatory disease” to “reducing at least one symptoms of an inflammatory disease in a subject”.
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 22, 24-25, 27-31 and 33-34 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 22 discloses “the method of claim 17”. As claim 17 has been withdrawn, it is not clear what this phrase intends to point out. Applicant is advised to disclose the structural limitation of the claimed mesenchymal lineage precursor or stem cells, or discloses the active steps of the withdrawn claim in the instant claim.
Claim 27 discloses “a treated subject” in line 2. It is not clear what subject matter this phrase intends to point out. Is it referring to the subject treated by the method of claim 22? It is vague what the subject being treated without clearly pointing out what the treatment is and whether or not “a subject” is the same subject as claim 22. Clarification is required.
Claim 33 discloses the percentages in the parentheses. It is not clear if the percentages are parts of the limitation or it is a mere suggestion or example. If the percentages are limiting, then applicant is advised to disclose positively without parentheses. Clarification is required.
Furthermore, it is not clear how the sum of the percentages of Plasma-Lyte A, DMSO and HSA solution is more than 100% in the composition. Clarification is required.
Claim 33 contains the trademark/trade name “Plasma-Lyte”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a salt solution/buffer and, accordingly, the identification/description is 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:
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) 22, 24-25, 27-31 and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Itescu et al. (WO2018/202853; IDS ref. FP24).
Regarding claims 22 and 25, Itescu et al. teach a method of treating immune or inflammatory disorders or GVHD by administering mesenchymal lineage precursor or stem cells (Abstract).
Regarding the limitation of “identified according to the method of claim 17” in claim 22, it is a product-by-process limitation. The product-by-process limitation only provides a structure to the product. However, as claim 17 is withdrawn, the limitation does not provide any structure to the composition of MLPSCs. Thus, the limitation does not provide any weight in determining patentability. Furthermore, the withdrawn method of claim 17 is directed to determining therapeutic efficacy but it does not necessarily select a specific population of MLPSCs.
Regarding claim 24 directed to the inflammatory disease being a T cell mediated inflammatory disease, Itescu et al. teach the limitation (para. 22).
Regarding claim 27, the wherein clause of the claim is directed to the result of the claimed method but does not require any active step to be performed. Thus, the limitation does not provide any weight in determining patentability of the claimed method. Furthermore, as the method taught by Itescu et al. is identical with the claimed method in its steps and materials being used, the results are expected the same.
Regarding claim 28 directed to the subject being refractory to steroid immunosuppressant, Itescu et al. teach that the MLPSCs are administered to the subject after the subject has been determined to be steroid refractory (para. 68).
Regarding claim 29 directed to the at least two doses of the composition being administered to the subject, Itescu et al. teach that the subject may receive two or more doses (para. 56).
Regarding claim 30, Itescu et al. teach that the mesenchymal lineage precursor or stem cells may be cryopreserved prior to administration to a subject (para. 151), and the isolated or enriched mesenchymal lineage precursor or stem cells can be cryopreserved, thawed and subsequently or further expanded ex vivo or in vitro by culture (para. 154). Itescu et al. also teach that the mesenchymal lineage precursor or stem cells are isolated, or isolated and enriched, cryopreserved, thawed and subsequently culture expanded (para. 36).
Regarding claim 31, Itescu et al. teach the mesenchymal lineage precursor or stem cells is a population of mesenchymal stem cells (para. 87).
Regarding claim 33, the percentage in the parenthesis is not considered limiting, and thus, the claim is interpreted as the composition further comprises Plasma-Lyte A, DMSO, and HSA. It is noted that the limitation directed to the HSA solution comprising 5% HSA and 15% buffer, the percentages of HSA and the buffer in the HSA solution do not provide the structure of the composition other than HSA and a buffer is mixed along with other components, e.g. PlasmaLyte-A and DMSO in the composition. The buffer is not particularly defined and thus, PlasmaLyte-A is considered to meet the buffer. Itescu et al. teach the use of PlasmaLyte, DMSO and HSA as claimed (para. 20, 236).
Thus, the reference anticipates the claimed invention.
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.
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) 22, 24-25, 27-31 and 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Itescu et al. (supra).
The teachings of Itescu et al. anticipate the subject matter of claims 22, 24-25, 27-31 and 33 as discussed above, and thus, they render the claimed invention obvious.
Regarding claim 34, while Itescu et al. teach the dosage of the MLPSCs is 2x106 cells/kg via intravenous injection (par. 402), however, they do not particularly teach the composition or a dose comprising greater than 6.68x106 viable cells/ml.
However, it would have been prima facie obvious to a person skilled in the art to determine optimal dose per injection based on the suitable volume of the injectable composition to achieve the desired outcome of treating GVHD with a reasonable expectation of success. By doing so, one skilled in the art would arrive the claimed dosage of greater than 6.68x106 cells/ml. For example, as 2x106 cells per kg of body weight of a subject are administered per injection, total cell number would be at least 108 cells per a person with 50 kg of body weight. As the injection volume per dose can be adjustable, the volume of 10 ml per injection would be at least 107 cells/ml. As such, the concentration of the cells utilized for the treatment of GVHD or an inflammatory disease would be considered as a result-effective parameter that can be readily modifiable by routine experimentations to arrive the claimed cell concentration.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
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 22, 24-25, 27-31 and 33-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 10-11, 16, 20, 37 of copending Application No. 18/723204 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘204 application disclose a method of treating GVHD in a subject by administering a composition comprising MLPSC. Regarding claim 27, claim 20 of the ‘204 application discloses that the treatment increases the probability of the subject surviving for at least 100 days.
Claim 6 of the ‘204 application discloses that the subject is steroid refractory (RE: claim 28).
Claim 46 of the ‘204 application discloses that the subject receives at least two doses (RE: claim 29).
Claim 30 of the ‘204 application discloses that the MLPSCs have been cryopreserved and culture expanded, and the MLPSCs are mesenchymal stem cells (RE: claims 30-31).
Claim 37 of the ‘204 application discloses the composition further comprising Plasma-Lyte A, DMSO, HAS and buffer (RE: claim 33) and the composition comprises greater than 6.68x106 viable cells/ml (RE: claim 34).
Thus, the claims of the ‘204 application render the claims of the instant application obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 22, 24-25, 27-31 and 33-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 10-13, 15, 24-26 of copending Application No. 17/904581 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘581 application disclose a method of treating GVHD by administering a composition comprising MLPSCs. As the claims of the ‘581 application disclose the identical method of treating GVHD as claimed in the instant application, the results of the ’581 application’s method are expected the same as the instant application (RE: claim 27).
Claim 1 of the ‘581 application discloses that the subject is refractory to a steroid immunosuppressant and/or a biologic therapy (RE: claim 28).
Claim 19 of the ‘581 application teach at least two doses (RE: claim 29).
Claim 1 of the ‘581 application teaches that the MLPSCs have been cryopreserved and culture expanded (RE: claim 30).
Regarding claim 31, claim 15 of the ‘581 application teaches that the MLPSCs are mesenchymal stem cells.
Regarding the other components of the composition (RE: claim 33), the claims of the ‘581 application disclose the identical components.
Regarding the concentration of the viable cells in claim 34 of the instant application, claim 26 of the ‘581 application teaches the identical limitation.
Thus, the claims of the ‘581 application render the claims of the instant application obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631