DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Preliminary amendment filed on 03/12/2024 has been entered. Claims 14 and 15 are new. Claims 1-15 are pending in this application and are currently under examination.
Priority
This application is a 371 of PCT/IB2022/058719 filed on 09/15/2022 and claims foreign priority of ITALY 102021000023903 filed on 09/16/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 03/12/2024 has been considered.
Claim Objections
Claims 1, 2, 7, and 9-12 are objected to because of the following informalities: In claim 1, insert the missing conjunction “and” immediately before the third component “- a mixture of amino acids” (line 6) and before the last component of amino acid mixture “L-arginine hydrochloride” (line 11). In claim 2, insert the missing conjunction “and” immediately before the recitation “1.5 mg/ml of L-Arginine HCI” (line 4). In claim 7, inserting the missing word “further” immediately before the recitation “comprising at least” (line 2), which is an additional component; and insert the missing unit “w/v” immediately after the percentage range at the end of the claim. In claim 9, delete the excessive recitation “comprised” (line 2). In claim 10, delete the incorrect recitation “composition or” (line 1) because the claim 9 is a kit; insert the missing phrase “wherein the kit is” immediately before the recitation “for use in the treatment” (line 2) to become a proper dependent claim; and change the incorrect recitation “deterioration and/or senescence, elastosis and dermoepidermal atrophy” (lines 2 to 3) to “deterioration, senescence, elastosis, or dermoepidermal atrophy” because they are distinct conditions. In claims 11 and 12, delete the incorrect recitation “use of the composition or” (line 1 of claims 11 and 12) because the claim 9 is a kit; and insert the missing phrase “, wherein the kit is used” immediately after the recitation “claim 9” (line 2) to become a proper dependent claim. Appropriate correction is required.
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 7 and 13 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 pre-AIA 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 7 recites the broad recitation “at least one of: physiological solution, pharmaceutically acceptable excipients or adjuvants”, and the claims also recite “a phosphate buffer… an anesthetic agent” 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. Applicant is advised to delete the recitation “at least one of”.
Claim 13 recites “A non-therapeutic method of skin treatment”, in which the “non-therapeutic” is not specifically defined and thus is not clear what the metes and bounds of the “non-therapeutic method” are. Applicant is advised to delete the recitation “non-therapeutic”.
Claim 13 recites the limitation "the intradermal injection of the composition according to claim 1". There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to change the above recitation to active step “intradermally injecting the composition according to claim 1".
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-12, 14, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon or a product of nature without significantly more. The 2019 Revised Patent Subject Matter Eligibility Guidance (issued January 7, 2019)” (https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf) and “October 2019 Update: Subject Matter Eligibility (issued October 17, 2019)” (https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf), are followed here. The claim is directed to a statutory category, e.g., a composition or a product of matter (Step 1: YES). The claim is then analyzed in Step 2A (Prong one) to determine whether it is directed to any judicial exception. The claims 1-20 recite an injectable composition (or a kit) comprising non cross-linked sodium hyaluronate with a molecular weight between 100 and 400 kDa; non cross-linked sodium hyaluronate with a molecular weight at least 2000 kDa; and a mixture of amino acids consisting of Glycine, L-Proline and/or L-Hydroxyproline, L-Alanine, L-Valine, L-Leucine, L-Lysine, and L-Arginine, which are products of nature. Accordingly, the claim is directed to at least one exception (Step 2A, prong one: YES). The claim is then analyzed in Step 2A (Prong two) and is determined that this judicial exception is not integrated into a practical application because there is no indication that mixing them in the recited concentrations (i.e., between 7 and 20 mg/ml or between 10 and 25 mg/ml non cross-linked sodium hyaluronate; between 6 and 12.5 mg/ml 9 mg/ml of Glycine; between 5 and 8 mg/ml or 6.5 mg/ml of L-Proline; between 1 and 5 mg/ml of L-Alanine, L-Valine, L-Leucine, L-Lysine, and L-Arginine) changes the structure, function, or other properties of the individual components in any marked way. Instead, the individual active retains its naturally occurring structure and properties (e.g., suitable for skin or joint injection or filler). Thus, the claimed mixture as a whole does not display markedly different characteristics compared to the closest naturally occurring counterpart. Accordingly, the Step 2A (Prong two) is NO. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because prior to applicant’s invention and at the time of filing the application, mixing of recited non cross-linked sodium hyaluronate and amino acid mixture was well-understood, routine and conventional in the field, as evidenced by the reference under the 103 rejection below. The recitation of specific concentrations of non cross-linked sodium hyaluronate and amino acid mixture, excipients or adjuvants, peptide, and optionally instructions, does not affect this analysis, because it was also well-understood, routine and conventional at the time to mix specific concentrations of non cross-linked sodium hyaluronate and amino acid mixture, excipients or adjuvants, peptide, and optionally instructions, e.g., to achieve commercially acceptable chemical complex for different purposes. Thus, the mixing of different concentrations of non cross-linked sodium hyaluronate and amino acid mixture, when recited at this high level of generality, does not meaningfully limit the claim, and the claim as a whole does not amount to significantly more than each “product of nature” by itself (Step 2B: NO). The claim does not qualify as eligible subject matter.
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.
(I) Claims 1-7 and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (KR20190012129, published on 2019-02-08, English translation available from Global Dossier, hereinafter referred to as Han ‘129) in view of Shin et al. (US 10,279,076, May 7, 2019, hereinafter referred to as Shin ‘076).
With regard to structural limitations “An injectable composition (or having a pH between 6.8 and 7.5) comprising: non cross-linked sodium hyaluronate with a molecular weight between 100 and 400 kDa in a concentration between 7 and 20 mg/ml (or 16 mg/ml; or 12 mg/ml); non cross-linked sodium hyaluronate with a molecular weight at least 2000 kDa, in a concentration between 10 and 25 mg/ml (or 16 mg/ml; or 20 mg/ml); and a mixture of amino acids consisting of Glycine in a concentration between 6 and 12.5 mg/ml (or 9 mg/ml), L-Proline and/or L-Hydroxyproline in a concentration between 5 and 8 mg/ml (or 6.5 mg/ml), L-Alanine in a concentration between 1 and 5 mg/ml (or 2 mg/ml), L-Valine in a concentration between 1 and 5 mg/ml (or 2.5 mg/ml), L-Leucine in a concentration between 1 and 5 mg/ml (or 1 mg/ml), L-Lysine hydrochloride in a concentration between 1 and 5 mg/ml (or 2.5 mg/ml), L-arginine hydrochloride in a concentration between 1 and 5 mg/ml (or 1.5 mg/ml)” (claims 1-6, 14, and 15), “further comprising: physiological solution, pharmaceutically acceptable excipients or adjuvants, a buffer, or a phosphate buffer in a concentration ranging from 0.1% to 0.4% w/v” (claim 7), “A kit comprising an injectable composition according to claim 1 in a pre-filled syringe and optionally comprising instructions for use” (claim 9), and “a method of skin treatment of a subject, comprising intradermally injecting the composition according to claim 1” (claim 13):
Han ‘129 disclosed a composition for improving in vivo persistence of polymeric hyaluronic acid and a skin filler composition for injection and has an effect of inhibiting the degradation of cross-linked hyaluronic acid by hyaluronidase. Hyaluronic acid is used not only as a cosmetic additive but also as a medicine for improving joint function. A composition for improving in vivo persistence of high molecular hyaluronic acid comprising low molecular hyaluronic acid having a weight average molecular weight of 5 kDa to 500 kDa, 100 kDa to 350 kDa, 150 kDa to 300 kDa, or 200 kDa to 280 kDa. The polymer hyaluronic acid may be applied without limitation as long as it has a molecular weight of 1000 kDa or more, and may be crosslinked. The low molecular weight hyaluronic acid may be included in an amount of 0.5 parts by weight to 5 parts by weight or 1.5 parts by weight to 3.5 parts by weight based on 100 parts by weight of the composition. The polymer hyaluronic acid may have a weight average molecular weight of 1,000 kDa to 5,000 kDa, in an amount of 1 part by weight to 20 parts by weight based on 100 parts by weight of the skin filler composition for injection (pages 5/27 to 9/27, [0001, 0002, 0012-0014, 0018]; page 11/27, [0032, 0034]). The composition may further include a basic amino acid having a cation at neutral pH and may bind to hyaluronic acid having a strong anion, so that the low molecular weight hyaluronic acid can stay in the hyaluronic acid gel for a long time in the body. The basic amino acid may be included in an amount of 0.1 parts by weight to 3 parts by weight based on 100 parts by weight of the composition. The basic amino acid may be one selected from lysine, arginine, histidine, and a combination thereof. The pH of the composition may be 6.0 to 8.0 in a buffer solution. The buffer includes physiological saline, phosphate buffered physiological saline. The “skin filler” refers broadly to materials or compositions designed to add a volume to a soft tissue deficient area. Examples include muscle, tendon, fibrous tissue, fat, blood vessels, nerves, and synovial tissue (tissue around the joint) (pages 9/27 to 10/27, [0019-0022, 0024-0028]). In order to confirm the inhibitory effect of basic amino acids (2% arginine, 2% lysin, 2% arginine + lysine, 2% histidine, 2% glycine, or 2% proline) on the release of low molecular hyaluronic acid, a skin filler composition for injection of a hyaluronic acid crosslinked gel having the composition as shown in table 2. As shown in fig. 3, the elution amount of hyaluronic acid was effectively reduced when the composition containing heat-treated hyaluronic acid and a basic amino acid (pages 14/27 to 16/27, [0048, 0049]; page 18/27, [0062]).
Han ‘129 did not explicitly disclose the limitations “L-Alanine in a concentration between 1 and 5 mg/ml (or 2 mg/ml), L-Valine in a concentration between 1 and 5 mg/ml (or 2.5 mg/ml), L-Leucine in a concentration between 1 and 5 mg/ml (or 1 mg/ml)”, and “A kit comprising an injectable composition according to claim 1 in a pre-filled syringe and optionally comprising instructions for use”, required by claims 1-7, 9, and 13-15.
Shin ‘076 disclosed a composition, which contains collagen hydrolysate as an active ingredient, can promote the synthesis of hyaluronic acid and inhibit the activity of hyaluronidase, useful in maintaining the effect of a hyaluronic acid filler for a longer period of time. The composition can be directly injected into the skin by simple parenteral administration. The 'hyaluronic acid filler' may mean a filler containing hyaluronic acid (HA) as a main ingredient. The composition may contain 0.01-50 wt% of collagen hydrolysate based on the total weight of the composition. The collagen hydrolysate may contain the collagen tripeptide Gly-X-Y. The X and the Y may be the same or different amino acids and the amino may be selected from a group consisting of glycine (Gly), alanine (Ala), valine (Val), leucine (Leu), isoleucine (Ile), threonine (Thr), serine (Ser), cysteine (Cys), methionine (Met), aspartic acid (Asp), asparagine (Asn), glutamic acid (Glu), glutamine (Gin), lysine (Lys), arginine (Arg), histidine (His), phenylalanine (Phe), tyrosine (Tyr), tryptophan (Trp) and proline (Pro). Specifically, the collagen tripeptide may include glycine-proline-hydroxyproline (col. 1, lines 65-67; col., 2, lines 1-19, 66, and 67; col. 3, lines 1, 26-28, and 43-56). The composition may further contain a humectant, an emollient, a UV absorbent, a preservative, a sterilizer, an antioxidant, a pH control agent, in an amount of 0.01-5 wt %, specifically 0.01-3 wt, based on the total weight of the composition. A kit for a filler treatment, containing: a filler composition comprising a hyaluronic acid; and a composition containing collagen hydrolysate as active ingredients. The filler composition may be an injection. The kit may further contain a written instruction (col. 4, lines 44-60).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to combine the filler composition comprising non-crosslinked hyaluronic acids of different molecular weight and amino acids of Han ‘129 with peptide lysate and/or amino acids in view of Shin ‘076 to improve in vivo persistence of hyaluronic acid by inhibiting the hyaluronidase because (a) both amino acids with properties of glycine, proline, lysine and arginine and peptide lysate inhibit degradation of hyaluronic acids by hyaluronidase enzyme, described above, (b) injection requires needle or syringe, and (c) the injectable composition of Han ‘129 in view of Shin ‘076 meets all structural limitation of claimed injectable composition and kit, and thus would be suitable for the treatment required by claims 10-12. Thus, one of skill in the art would have a reasonable expectation that by combining the filler composition comprising non-crosslinked hyaluronic acids of different molecular weight and amino acids of Han ‘129 with peptide lysate and/or amino acids in view of Shin ‘076 to improve in vivo persistence of hyaluronic acid by inhibiting the hyaluronidase, one would achieve Applicant’s claims 1-7 and 9-15. “In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious)”. See MPEP § 2144.06 [R-01.2024] [I].
(II) Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (KR20190012129, published on 2019-02-08, English translation available from Global Dossier, hereinafter referred to as Han ‘129) in view of Shin et al. (US 10,279,076, May 7, 2019, hereinafter referred to as Shin ‘076), as applied to claims 1-7 and 9-15, and further in view of Chung et al. (WO 2007/049904, May 3, 2007, hereinafter referred to as Chung ‘904).
The above disclosure of Han ‘129 in view of Shin ‘076 is incorporated by the reference in its entirety here. Han ‘129 in view of Shin ‘076 did not explicitly disclose the limitation “Acetyldecapeptide 3 of SEQ ID NO: 1 (= Ac-Tyr-Arg-Ser-Arg-Lys-Tyr-Thr-Ser-Trp-Tyr-NH2)”, required by claim 8.
Chung ‘904 disclosed bFGF-derived peptides. The peptides promote the proliferation of fibroblasts or keratinocytes, induce the biosynthesis of procollagen, laminin, hyaluronic acid and fibronectin to regenerate keratinocyte layer, epidermis and dermis, thereby resulting in the improvements in wrinkle, skin elasticity and skin moisture EXAMPLE 4: Synthesis and Purification of Ac-Decapeptide (Ac-YRSRKYTSWY-NH2) (page 6/52, lines 7-24; page 16/52, lines 7-26).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to combine the filler composition comprising non-crosslinked hyaluronic acids of different molecular weight and amino acids, and/or peptide lysate as taught by Han ‘129 in view of Shin ‘076 with Ac-Decapeptide (Ac-YRSRKYTSWY-NH2) further in view of Chung ‘904 to improve in vivo persistence of hyaluronic acid by inhibiting the hyaluronidase and to improve skin elasticity and moisture, described above. Thus, one of skill in the art would have a reasonable expectation that by combining the filler composition comprising non-crosslinked hyaluronic acids of different molecular weight and amino acids, and/or peptide lysate as taught by Han ‘129 in view of Shin ‘076 with Ac-Decapeptide (Ac-YRSRKYTSWY-NH2) further in view of Chung ‘904, one would achieve Applicant’s claim 8. “In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious)”. See MPEP § 2144.06 [R-01.2024] [I].
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
(I) Claims 1-6, 14, and 15 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-6, 15, and 16 of copending Application No. 18/691,052 (Applicant: PROFESSIONAL DERMA SA, claim set of 03/12/2024). Claims 1, 2, 3, 4, 5, 6, 15, and 16 of Appl ‘052 are mapped to claims 1, 2, 3, 4, 5, 6, 14, and 15 of this Application. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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.
(II) Claims 1-7, 9-12, 14, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10, 15, and 16 of copending Application No. 18/691,052 (Applicant: PROFESSIONAL DERMA SA, claim set of 03/12/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because Appl ‘052 claims “The composition according to claim 1, comprising at least one of: physiological solution, pharmaceutically acceptable excipients or adjuvants, a buffer, a phosphate buffer, or an anesthetic agent, a local anesthetic agent, or lidocaine, in a concentration ranging from 0.1% to 0.4%” (claim 7), and “A kit comprising an injectable composition according to claim 1, comprised in a pre-filled syringe and optionally comprising instructions for use” (claim 10), along with claims 1-6, 15, and 16 of Appl ‘052, as indicated in the statutory ODP above, read on claims 1-7, 9-12, 14, and 15 of this Application, including properties or intended purposes recited in claims 10-12 of this Application. 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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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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