Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 12, 2026 has been entered.
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
3. Applicant’s amendment filed May 12, 2026 is acknowledged. Claims 2-15, 17-19 and 22-37 are canceled. Claim 1 is amended. Claims 1, 16, 20-21 and 38-40 are pending in this application. Election was made without traverse in the reply filed on January 18, 2023.
4. Claims 1, 16, 20-21 and 38-40 are under examination with respect to SLE in this office action.
5. Applicant’s arguments filed on May 12, 2026 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections/Objections Withdrawn
6. The rejection of claims 1 and 20-21 under pre-AIA 35 U.S.C. 102(e) as being anticipated by Itescu’375 (US8828375) is withdrawn in response to Applicant’s amendment to the claims.
The rejection of claim 10 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ichim et al. (US2009/0053182) in view of Gronthos et al. (US8367405), Itescu’978 (US9301978) and Itescu’375 (US8828375) is moot because the claim is canceled.
Claim Rejections/Objections Maintained
In view of the amendment filed on May 12, 2026, the following rejections are maintained.
Claim Rejections - 35 USC § 103
7. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 16, 20-21 and 38-40 stand rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Itescu’375 (US8828375) in view of Ichim et al. (US2009/0053182) and Itescu’978 (US9301978). The reference of Gronthos et al. (US8367405) is withdrawn in response to Applicant’s amendment to the claims. The rejection is maintained for the reasons of record and the reasons set forth below.
Claims 1, 16, 20-21 and 38-40 as amended are drawn to a method for treating or delaying progression of systemic lupus erythematosus (SLE) in a subject, comprising administering to the subject an amount of a population of cells effective to treat or delay progression of the SLE, wherein the population of cells comprises STRO-1+ TNAP+ multipotential cells (STRO-1+ TNAP+-MPCs) and wherein the population of cells is administered systemically, and wherein
(i) the amount of the population of cells comprising STRO-1+ TNAP+ multipotential cells is effective to increase the number of regulatory T (Treg) cells in the subject and/or at the site of pathogenesis of systemic lupus erythematosus; and
(ii) from 2x106 to 8x106 STRO-1+ TNAP+ multipotential cells are administered per kg of the subject's body weight.
Itescu’375 teaches a method of treating a subject having SLE (see col.4 line 2; col. 17-18, claims 1-3, 9 and 18), comprising administering or transplanting a cell population comprising STRO-1+/bright TNAP+-multipotential cells or mesenchymal precursor cells (MPCs) (see col. 6, lines 1-31; col. 6, lines 23-28; lines 40-67) to the subject in an amount sufficient to treat the SLE (see col.4 line 2; col. 17-18, claims 1-3, 9 and 18) by systemic administration (see col.10, lines 1-5), wherein the population comprising HPCs and a cell population enriched for STRO-1+TNAP+-MPCs is autogenic or allogenic as in claim 20 (see col.2, lines 38-39; col.7, lines 55-67; col. 8, lines 1-67;), and wherein the population comprising HPCs and a cell population enriched for STRO-1+TNAP+ MPCs have been culture-expended prior to administration as in claim 21 (see col. 2, lines 19-59; col.7, lines 55-67; col. 8, lines 1-67). The STRO-1+/bright TNAP+-multipotential cells or mesenchymal precursor cells (MPCs) disclosed by Itescu’375 are multipotential cells as the claimed multipotential cells that are defined by WO2006/032092 as described in para. [0106] of the instant application (see col.7, lines 55-67; col. 8, lines 1-67; col. 5, lines 56-col.6, line 31). Itescu’375 teaches a dose of 1x107 TNC/kg (TNC: total nuclear cells) or 1x107-4x107TNC/kg (see col.2, line 9-10; col.9, lines 37-39).
But Itescu’375 does not teach the claimed dose ranges: “2x106 to 8x106/kg” in claim 1, “3x106 to 6x106/kg” in claim 38, “0.1x106 to 3x106/kg” in claim 39 or “3x106/kg” in claim 40, or he regimen of administration of the cells once weekly or once every four weeks (monthly) in claim 16.
Ichim teaches a method for treating a subject having an autoimmune disorder including systemic lupus erythematosus (SLE) (see para. [0115]; example 17, para. [0216]-[0218]), comprising administering to the subject in need thereof via systemic administration (see para. [0136]) a cell population comprising pluripotent stem cells including STRO-1+ pluripotent stem cells (see para. [0004]; [0043]) at a dose range including 0.5x106-500x106 or 1x106-100x106, 3x106 cells (see para. [0133];[0216]-[0218], Example 17). Ichim teaches different regimens and frequencies including one or more times (e.g., 1-10, 1-5 or 1-3 times) per day, week, month, or year; or every second day for a total of 4 injections, 1-7 times per week, for 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, or more weeks, and any numerical value or range or value within such ranges (see para. [0134]). Ichim teaches that the cell population is an autogenic or allogeneic population as related in claim 20and is culture expanded prior to administration as in claim 21 (see para. [0120]; [0132]; [0239]; [0272]), the population of cells is culture expanded prior to administration in claim 21 (see para. [0121]; [0136]), which comprises STRO-1+ pluripotent stem cells and STRO-1+ multipotent cells.
Itescu’978 teaches a method of using a cell composition enriched for STRO-1+/bright TNAP+-MPCs for treating immunological diseases including GvHD to increase the number of Treg (see col.5, lines 31-52) at different dose ranges including 0.01-5x106 cells/kg body weight, 0.1-0.5x106 or 0.3x106/kg body weight or 1x105-1x107/kg, 1x106-5x106/kg for treatment (see col. 7, lines 5-20; col. 16, lines 3-11; col. 37-38, claims 7-10), which are within or overlapping with the claimed ranges “2x106 to 8x106/kg” in claim 1, “3x106 to 6x106/kg” in claim 38, “0.1x106 to 3x106/kg” in claim 39 or “3x106/kg” in claim 40. Itescu’978 teaches different regimens and frequencies including once weekly as in claim 16 (see col. 18, lines 31-36; col. 38, claim 11), wherein the STRO-1+/bright TNAP+-MPCs are autogenic or allogeneic in claim 20 (see col. 37-38, claims 4), the population of cells is culture expanded prior to administration in claim 21 (see col. 15, line 66-col.16, line 2). Itescu’978 teaches human multipotential cells (MPCs) express both STRO-1+/bright and TNAP+ (STRO-1+/bright TNAP+-MPCs) because human MPCs in human bone marrow are exclusively restricted to the TNAP positive fraction of human BM which co-express the STRO-1 antigen brightly (STRO-1+/bright TNAP+-MPCs), and the TNAP+ cells selected using STRO-3 mAb are STRO-1+/bright (see col., lines 40-55; col. 7, lines 63-col.8, line 3; lines 18-20; col. 11, lines 7-15; col. 12, lines 20-2; col.20, Example 3).
A person of ordinary skill in the art would have recognized that applying the known dose range of 0.5x106-500x106 or 1x106-100x106, or 3x106 cells, or 0.01-5x106 cells/kg body weight, 0.1-0.5x106 or 0.3x106/kg body weight or 1x105-1x107/kg, 1x106-5x106/kg body weight and the known treatment regimens and frequencies disclosed by Ichim and Itescu’978 to the Itescu’375’s method would have yield the predictable result of treating SLE or delaying disease progression of SLE in a subject suffering from SLE, and resulted in an improved method of treating SLE or delaying disease progression of SLE.
Using a cell population enriched for STRO-1+TNAP+-MPCs at a dose range of 0.5x106-500x106 or 1x106-100x106 or 3x106 cells, or 0.01-5x106 cells/kg body weight, 0.1-0.5x106 or 0.3x106/kg body weight or 1x105-1x107/kg, 1x106-5x106/kg and different treatment regimens and frequencies can treat SLE, and would expand application of the Itescu’375’s method, and increase patient’s satisfaction with recommended treatment regimens because the dose range of 0.5x106-500x106 or 1x106-100x106 or 3x106 cells, or 0.01-5x106 cells/kg body weight, 0.1-0.5x106 or 0.3x106/kg body weight or 1x105-1x107/kg, 1x106-5x106/kg, which are within or overlapping with the claimed dose ranges, and the claimed regimens and frequencies have been used for treatment of SLE and increasing Treg numbers.
Further, the claimed method requires a dose range of 2-8x106, 3-6x106 or a low dose: 0.1-3x106 or about 3x106 cells per kg, which overlaps with the ranges of Ichim and Itescu’978 because Ichim teaches different doses including 0.5x106-500x106 or 1x106-100x106 cells, 3x106 and Itescu’978 teach 0.01-5x106 cells/kg body weight, 0.1-0.5x106 or 0.3x106/kg body weight or 1x105-1x107/kg, 1x106-5x106/kg for treatment. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known dose range of 0.5x106-500x106 or 1x106-100x106, or 3x106 cells, or 0.01-5x106 cells/kg body weight, 0.1-0.5x106 or 0.3x106/kg body weight or 1x105-1x107/kg, 1x106-5x106/kg body weight and the known treatment regimens and frequencies disclosed by Ichim and Itescu’978 to the Itescu’375’s method and yield the predictable result of treating SLE or delaying disease progression of SLE in a subject suffering from SLE.
Response to Arguments
On p. 5-9 of the response, Applicant argues that: i) Ichim is directed to the use of pluripotent stem cells, which are not multipotential cells because the pluripotent cells derived from menstrual blood or differentiated cells derived from those pluripotent cells; and pluripotent cells are able to differentiate into any cell type whereas multipotent cells can form multiple but not every cell type and only restricted to their tissue origin; Ichim does not teach or suggest the use of multipotential cells, the STRO-1 marker is only discussed in paragraph [0043], and cells with a STRO-1 marker proliferating at a rate of 0.5-0.9 doubling per 24hours and cited para. [0004] an [0175]; ii) Gronthos discloses that STRO-1+ TNAP+ cells can differentiate into cells for treating bone conditions including spinal disc fusion or removal but not treatment of SLE; iii) Itescu’978 teaches the use of STRO-1+ TNAP+-MPCs to treat GvHD, which is unrelated to SLE. iv) Itescu’375 is no longer relevant to the number recited in amended claim 1. v) the STRO-1bright MPCs express immune-protective protein SDF-alpha and RNAKL with a much higher level than STRO-1dull MPCs (Example 1), and the STRO-1+/bright TNAP+ MPCs reduce or prevent T cell immune response to a specific antigen such as MOG even after the last administration (Example 5).
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2141, MPEP2141-I, rationales identified by the Court in KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), MPEP2141-II, the basic factual inquires of Graham v. John Deere Co.(Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)),and MPEP §2141.01-2147.03, the cited references do render the claimed invention obvious because:
i. Applicant cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this case, Itescu’375 teaches a method of using the same material and the same active step in the same patient population except the dose range of cells recited in claim 1 because Itescu’375 teaches a method of treating a subject having SLE (see col.4 line 2; col. 17-18, claims 1-3, 9 and 18), comprising administering or transplanting a cell population comprising STRO-1+/bright TNAP+-multipotential cells or mesenchymal precursor cells (MPCs) (see col. 6, lines 1-31; col. 6, lines 23-28; lines 40-67) to the subject in an amount sufficient to treat the SLE (see col.4 line 2; col. 17-18, claims 1-3, 9 and 18) by systemic administration (see col.10, lines 1-5), wherein the population comprising HPCs and a cell population enriched for STRO-1+TNAP+-MPCs is autogenic or allogenic (see col. 37-38, claims 4), and wherein the cell population is cultured to expand prior to administration (see col. 15, line 66-col.16, line 2).
While Itescu’375 does not teach the claimed dose ranges of 2-8x106, 3-6x106 or 0.1-3x106 or 3x106 cells per kg in claims 1 and 38-40 or frequency of once weekly or once every four weeks as in claim 16, Ichim and Itescu’978 teach these limitations and provide motivation and an expectation of success because dose ranges either within or overlapping with the claimed dose ranges and the claimed regimens have been used for treatment of SLE and increasing Treg numbers as taught by Ichim and Itescu’978.
In particular, Ichim teaches a method for treating a subject having an autoimmune disorder including systemic lupus erythematosus (SLE) (see para. [0115]; example 17, para. [0216]-[0218]), comprising systemically administering (see para. [0136]) to the subject in need thereof a cell population comprising pluripotent stem cells including STRO-1+ pluripotent stem cells (see para. [0004]; [0043]) at a dose range including 0.5x106-500x106 or 1x106-100x106, 3x106 cells (see para. [0133];[0216]-[0218], Example 17) and using different regimens and frequencies including one or more times (e.g., 1-10, 1-5 or 1-3 times) per day, week, month, or year; or every second day for a total of 4 injections, 1-7 times per week, for 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, or more weeks, and any numerical value or range or value within such ranges (see para. [0134]). The cell population comprising STRO-1+ pluripotent stem cells disclosed by Ichim is culture expanded prior to administration (see para. [0120]-[0121]; [0132]; [0136]; [0239]; [0272]), which comprises STRO-1+ pluripotent stem cells and STRO-1+ multipotent cells.
Itescu’978 teaches a method of using a cell composition enriched for STRO-1+/bright TNAP+-MPCs for treating immunological diseases including GvHD to increase the number of Treg (see col.5, lines 31-52) at different dose ranges including 0.01-5x106 cells/kg body weight, 0.1-0.5x106 or 0.3x106/kg body weight or 1x105-1x107/kg, 1x106-5x106/kg for treatment (see col. 7, lines 5-20; col. 16, lines 3-11; col. 37-38, claims 7-10), which are within or overlapping with the claimed ranges “2x106 to 8x106/kg” in claim 1, “3x106 to 6x106/kg” in claim 38, “0.1x106 to 3x106/kg” in claim 39 or “3x106/kg” in claim 40. Itescu’978 teaches different regimens and frequencies including once weekly as in claim 16 (see col. 18, lines 31-36; col. 38, claim 11), wherein the STRO-1+/bright TNAP+-MPCs are autogenic or allogeneic in claim 20 (see col. 37-38, claims 4), the population of cells is culture expanded prior to administration in claim 21 (see col. 15, line 66-col.16, line 2). Itescu’978 teaches human multipotential cells (MPCs) express both STRO-1+/bright and TNAP+ (STRO-1+/bright TNAP+-MPCs) because human MPCs in human bone marrow are exclusively restricted to the TNAP positive fraction of human BM which co-express the STRO-1 antigen brightly (STRO-1+/bright TNAP+-MPCs), and the TNAP+ cells selected using STRO-3 mAb are STRO-1+/bright (see col., lines 40-55; col. 7, lines 63-col.8, line 3; lines 18-20; col. 11, lines 7-15; col. 12, lines 20-2; col.20, Example 3).
A person of ordinary skill in the art would have recognized that applying the known dose range of 0.5x106-500x106 or 1x106-100x106, or 3x106 cells, or 0.01-5x106 cells/kg body weight, 0.1-0.5x106 or 0.3x106/kg body weight or 1x105-1x107/kg, 1x106-5x106/kg body weight and the known treatment regimens and frequencies disclosed by Ichim and Itescu’978 to the Itescu’375’s method would have yield the predictable result of treating SLE or delaying disease progression of SLE in a subject suffering from SLE, and resulted in an improved method of treating SLE or delaying disease progression of SLE.
Using a cell population enriched for STRO-1+TNAP+-MPCs at a dose range of 0.5x106-500x106 or 1x106-100x106 or 3x106 cells, or 0.01-5x106 cells/kg body weight, 0.1-0.5x106 or 0.3x106/kg body weight or 1x105-1x107/kg, 1x106-5x106/kg and different treatment regimens and frequencies can treat SLE, and would expand application of the Itescu’375’s method, and increase patient’s satisfaction with recommended treatment regimens because the dose range of 0.5x106-500x106 or 1x106-100x106 or 3x106 cells, or 0.01-5x106 cells/kg body weight, 0.1-0.5x106 or 0.3x106/kg body weight or 1x105-1x107/kg, 1x106-5x106/kg, which are within or overlapping with the claimed dose ranges, and the claimed regimens and frequencies have been used for treatment of SLE and increasing Treg numbers.
Further, the claimed method requires a dose range of 2-8x106, 3-6x106 or a low dose: 0.1-3x106 or about 3x106 cells per kg, which overlaps with the ranges of Ichim and Itescu’978 because Ichim teaches different doses including 0.5x106-500x106 or 1x106-100x106 cells, 3x106 and Itescu’978 teach 0.01-5x106 cells/kg body weight, 0.1-0.5x106 or 0.3x106/kg body weight or 1x105-1x107/kg, 1x106-5x106/kg for treatment. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known dose range of 0.5x106-500x106 or 1x106-100x106, or 3x106 cells, or 0.01-5x106 cells/kg body weight, 0.1-0.5x106 or 0.3x106/kg body weight or 1x105-1x107/kg, 1x106-5x106/kg body weight and the known treatment regimens and frequencies disclosed by Ichim and Itescu’978 to the Itescu’375’s method and yield the predictable result of treating SLE or delaying disease progression of SLE in a subject suffering from SLE.
Accordingly, the rejection of claims 1, 16, 20-21 and 38-40 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Itescu’375 in view of Ichim and Itescu’978 is maintained.
ii. In response to Applicant’s arguments related to surprising findings, the Examiner asserts that the use of the claimed cell population comprising STRO-1+/bright TNAP+-MPCs for treating SLE is not unexpected because STRO-1+/bright and TNAP+ multipotent cells (STRO-1+/bright TNAP+-MPCs) has been used for treating SLE as taught by Itescu’978 and the use of a cell population comprising STRO-1+/bright-MPCs enriched for STRO-1+/bright TNAP+ at a dose range either within or overlapping with the claimed dose range has been used to increase the number of T regulatory cells and prevent T cell immune response to specific antigen as taught by Itescu’978.
Note that any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. See: MPEP §716.02. “A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue.” In re Corkill, 711 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985). See MPEP 716.02(a)-I.
The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342,1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “ See MPEP § 2112.01 [R-3].
Further, evidence of unexpected results is frequently in the form of a direct comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See: e.g., In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). In this case, Applicants fails to provide evidence of side-by-side comparisons to demonstrate unexpected results as claimed. “Evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978).” See MPEP 716.02(c)-I. Since Applicant fails to provide any evidence to support any unexpected results as claimed, the claimed method is obvious over the prior art, absent evidence to the contrary.
Accordingly, the rejection of claims 1, 16, 20-21 and 38-40 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Itescu’375 in view of Ichim and Itescu’978 is maintained.
New Grounds of Rejection Necessitated by the Amendment
The following rejections are new grounds of rejections necessitated by the amendment filed on May 12, 2026.
Claim Rejections - 35 USC § 112
8. 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 39 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 pre-AIA the applicant regards as the invention.
Claim 39 is indefinite because claim 39 recites both narrow and broad limitations. Claim 39 recites “(ii) from 0.1x106 to 3x106….” and also depends from claim 1 that recites “(ii) from 2x106 to 8x106….”. The lower end limit of the range recited in independent claim 1 is “2x106” which is narrower limitation, whereas the lower end limit of the range recited in claim 39 is “0.1x106”, which is broader limitation. 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 39 recites the broad recitation “0.1x106”, and the claim also depends on claim 1 that recites “2x106” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 112
9. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 39 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 39 recites “(ii) from 0.1x106 to 3x106….” and also depends on claim 1 that recites “(ii) from 2x106 to 8x106…” The lower end limit of the range recited in independent claim 1 is “2x106”. However, the lower end limit of the range recited in claim 39 is “0.1x106”, which does not further limit the subject matter of the claim upon which it depends and does not include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
10. NO CLAIM IS ALLOWED.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANG-YU WANG whose telephone number is (571)272-4521. The examiner can normally be reached Monday-Thursday, 7:00am-5:00pm EST.
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Chang-Yu Wang
June 27, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675
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