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 .
Claim Status
The original claim set filed 9 April 2025 is acknowledged. Claims 1-8 are currently pending. Claims 1-8 will be examined on the merits herein.
Priority
The instant application is a continuation of application 18/530,981 (filed 6 Dec 2023), which is a continuation of application 17/070,747 (filed 14 Oct 2020), and has a provisional application 62/915,360 (filed 15 Oct 2019). The effective filing date used for searching all claims is 15 Oct 2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10 June 2025 and 22 April 2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies of these statements are attached with this action.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, or were also cited in one of the considered IDSes, they have not been considered.
Specification
The disclosure is objected to because of the following informalities:
[0276] reads “Figure 141” 4 lines from the bottom but should read “14I” (the final digit should be the letter I rather than the number 1). Appropriate correction is required.
Also, [0294-0295] teach the samples administered to Group 2 are “CCFI”, which is a previously undefined abbreviation, but [0297] says Group 2 was administered EN3835. If this is an error that can be corrected without introducing new matter, applicant is requested to do so.
Claim Interpretation
Regarding claim 1, the limitation using past tense (“as measured at 60 days”) is interpreted as a requirement to measure the McGill Pain Scale results following administration rather than as an inherent result from the administration process, as in the allowed parent case with U.S. Patent No. 11,872,267.
Claim Rejections - 35 USC § 112(d)
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 pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 8 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.
Independent claim 1 recites “A method for reducing pain associated with a uterine fibroid in a patient”. Claim 7 depends from claim 1 and recites “the method further reduces one or more symptoms associated with uterine fibroids in the patient” and claim 8 depends from claim 7 and specifies “wherein the one or more symptoms are pain, bloating, pressure, bleeding, pre-term labor, infertility, or a combination thereof.” Dependent claim 8 is satisfied by the pain reduction from independent claim 1, so claim 8 does not further limit claim 1. Additionally, claim 7 limits claim 1 (“further reduces one or more symptoms”) so claim 8 does not include this limitation from 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.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Leppert et al. (US-20140271612-A1; hereafter Leppert; cited in IDS filed 10 June 2025) in view of Feng et al. (2010; hereafter Feng; PTO-892) and Donnez et al. (2012; hereafter Donnez; PTO-892).
Regarding claims 1, 6, and 8, Leppert teaches “methods for treating uterine fibroids, wherein a uterine fibroid treatment agent comprising collagenase in an amount effective to cause shrinkage of uterine fibroids is injected or inserted into the uterine fibroid.” [Abstract]. Leppert teaches that the therapeutic effect of the collagenase composition includes a reduction in symptoms such as pain [0058]. Leppert teaches that fibroid tissue reduction symptoms can be measured at 4 days or 7 days [0079].
Regarding instant claim 2, Leppert teaches that “preferred methods use a syringe and needle under ultrasound or other visualization for guided injection” [0035].
Regarding claims 3-5, Leppert teaches “doses generally are about 0.06 mg collagenase to about 1 mg collagenase per cm3 of tissue to be treated or about 0.1 mg collagenase to about 0.8 mg collagenase per cm3 of tissue to be treated, or about 0.2 mg collagenase to about 0.6 mg collagenase per cm3 of tissue to be treated.” [0088]. The smallest disclosed range is an example within the ranges of instant claims 3-4 and therefore anticipates the claimed ranges, see MPEP 2131.03. The smallest disclosed range also substantially overlaps with the range of instant claim 5, and therefore the claim is prima facie obvious over the disclosed range as there is no evidence that the claimed range is critical. See MPEP 2144.05: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding claims 7-8, Leppert teaches that the therapeutic effect of the collagenase composition includes a reduction in symptoms such as hemorrhage (i.e. bleeding) [0058].
Leppert does not teach that the reduction in pain measured on the McGill Pain Scale as measured at 60 days following the administration, as in claims 1 and 6.
Regarding claims 1 and 6, Feng teaches measuring pain in subjects with fibroids, and specifically teaches that the McGill Pain Scale is used (Abstract). Feng also teaches that pain measurements are taken at baseline, 3 months, and 6 months (Abstract).
Regarding claims 1 and 6, Donnez teaches measuring pain in subjects with fibroids (Abstract), and specifically teaches that the McGill Pain Scale is used at 13 weeks (Table 2 on pg. 426).
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the Leppert method of treating uterine fibroids and their associated pain by measuring pain using a scale that is well-known in the field (McGill Pain Scale) as taught by its use by both Feng and Donnez, because using a validated, well-known pain symptom measurement tool allows one of ordinary skill in the art to compare the efficacy of the collagenase therapy of Leppert with other art-known fibroid therapies. Therefore the combination would be desirable because the direct comparison using the same pain measurement scale makes it easier for those in the field to identify the most effective therapies for patients and the most promising potential therapies for further development. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.”
The modification to perform the McGill Pain Scale could be performed with a reasonable expectation of success because it is well known in the art at the time of filing, as evidenced by its use in multiple other fibroid therapy studies. The outcome of observing a reduction of at least 1 point or at least 15 points, as in claims 1 and 6, occurs with a reasonable expectation of success because composition disclosed in Leppert is identical to the claimed composition because it is a species within the claimed genus and the identical composition is also administered in the same manner and to the same subjects as the claims. Applicant has disclosed in the instant specification that the claimed composition has the claimed functions. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that applying a known technique to a known device, method or product ready for improvement is obvious because a particular known technique is recognized as part of the ordinary capabilities of one skilled in the art. In the instant case, Leppert contains a “base” method of treating pain associated with fibroids; and both Feng and Donnez contain a similar method for treating pain associated with fibroids wherein the technique of measuring pain levels with the McGill Pain Scale is taught as advantageous to understand the efficacy of the therapy. Thus, one of ordinary skill in the art would have recognized that applying the known technique taught by Feng and Donnez would have yielded predictable results (i.e. the same advantages) and an improved system.
One of ordinary skill in the art at the time of filing would further consider it prima facie obvious to modify the combination’s method of treating uterine fibroids and their associated pain that measures pain using a scale that is well-known in the field (McGill Pain Scale) by taking the measurement at 60 days following administration, because the art collectively teaches taking measurements for effects within the range of a few months after treatment is administered, and there is no evidence that the 60 day measurement is critical. Instead, it appears to be an arbitrarily chosen time range within the range disclosed in the art as being relevant for measuring symptom changes after a fibroid treatment is applied. MPEP 2144.05 states: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)… A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004). … Applicants can rebut a prima facie case of obviousness by showing the criticality of the range.” Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-12 of U.S. Patent No. 11,872,267. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1 and 8, ‘267 claim 7 teaches “A method for reducing pain associated with a uterine fibroid in a patient, the method comprising: administering into the uterine fibroid in the patient a composition comprising Clostridium histolyticum collagenase I and collagenase II in a 1:1 mass ratio to thereby reduce the pain associated with the uterine fibroid, wherein the patient has a reduction of at least 1 point on the McGill Pain Scale as measured at 60 days following the administration.” This is identical to instant claim 1 except for claiming a narrower collagenase composition. A disclosure of a species anticipates a genus, see MPEP 2131.02.
Regarding instant claims 2-6, ‘267 claims 8-12 teach the identical limitations.
Regarding instant claim 7, this claim recites an in vivo effect that occurs within the body within the body after the administration step and that is not connected to the step of measuring the pain levels. The composition disclosed in ‘267 is identical to the claimed composition because it is a species within the claimed genus and the identical composition is also administered in the same manner and to the same subjects as the claims. Applicant has disclosed in the instant specification that the claimed composition has the claimed functions. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 9,744,138 in view of Leppert et al. (US-20140271612-A1; hereafter Leppert; cited in IDS filed 10 June 2025), Feng et al. (2010; hereafter Feng; PTO-892), and Donnez et al. (2012; hereafter Donnez; PTO-892).
Regarding claim 1, ‘138 claim 1 (and dependent claims) teaches “A method for the treatment of uterine fibroids in a patient comprising: injecting or inserting into the uterine fibroid a composition comprising: … (b) collagenase…” Also, ‘138 claim 6 (and dependent claims) teaches “A composition for treating uterine fibroids in a patient comprising: …(b) collagenase,…” wherein the composition is formulated to be administered to uterine fibroid tissue. Also, ‘138 claim 21 (and dependent claims) teaches “A composition for treating uterine fibroids in a patient comprising: …(b) collagenase,…” Also, claim ‘138 claim 26 (and dependent claims) teaches “A method for the treatment of uterine fibroids in a patient comprising: injecting or inserting into the uterine fibroid a composition comprising: … (b) collagenase,…” The product claims also anticipate the instant method because they teach administering the same product to the same subject population claimed in the same manner claimed; see MPEP 2112.02: “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.”
Regarding claim 2, ‘138 claims 1, 5, 14, 15, and 26-27 teach injection of the composition. Specifically, ‘138 claim 15 teaches injection via a syringe.
Regarding claims 3-5, ‘138 claims 1, 3-4, 6, 19-20, 21-26, and 28-31 teach dosages of collagenase that are narrower and thus anticipate at least one of these claims. Specifically, ‘138 claim 6 teaches that the composition can be formulated to provide about 1 mg collagenase per dose administered to 1 cm3 of uterine fibroid tissue, which anticipates all claimed ranges.
The claims of ‘138 do not teach that the collagenase treatment has there is a reduction in pain measured on the McGill Pain Scale as measured at 60 days following the administration, as in claims 1, 6, and 8. The claims of ‘138 do not teach that there is a further reduction in one or more symptoms associated with uterine fibroids, as in claim 7.
Regarding claims 1, 6, and 8, Leppert teaches “methods for treating uterine fibroids, wherein a uterine fibroid treatment agent comprising collagenase in an amount effective to cause shrinkage of uterine fibroids is injected or inserted into the uterine fibroid.” [Abstract]. Leppert teaches that the therapeutic effect of the collagenase composition includes a reduction in symptoms such as pain [0058]. Leppert teaches that fibroid tissue reduction symptoms can be measured at 4 days or 7 days [0079].
Regarding instant claim 2, Leppert teaches that “preferred methods use a syringe and needle under ultrasound or other visualization for guided injection” [0035].
Regarding claims 3-5, Leppert teaches “doses generally are about 0.06 mg collagenase to about 1 mg collagenase per cm3 of tissue to be treated or about 0.1 mg collagenase to about 0.8 mg collagenase per cm3 of tissue to be treated, or about 0.2 mg collagenase to about 0.6 mg collagenase per cm3 of tissue to be treated.” [0088]. The smallest disclosed range is an example within the ranges of instant claims 3-4 and therefore anticipates the claimed ranges, see MPEP 2131.03. The smallest disclosed range also substantially overlaps with the range of instant claim 5, and therefore the claim is prima facie obvious over the disclosed range as there is no evidence that the claimed range is critical. See MPEP 2144.05: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding claims 7-8, Leppert teaches that the therapeutic effect of the collagenase composition includes a reduction in symptoms such as hemorrhage (i.e. bleeding) [0058].
Regarding claims 1 and 6, Feng teaches measuring pain in subjects with fibroids, and specifically teaches that the McGill Pain Scale is used (Abstract). Feng also teaches that pain measurements are taken at baseline, 3 months, and 6 months (Abstract).
Regarding claims 1 and 6, Donnez teaches measuring pain in subjects with fibroids (Abstract), and specifically teaches that the McGill Pain Scale is used at 13 weeks (Table 2 on pg. 426).
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the treatment from the claims of ‘138 of uterine fibroids by administering collagenase by measuring the effect on pain, as taught by Leppert, using a scale that is well-known in the field (McGill Pain Scale), as taught by both Feng and Donnez, because Leppert teaches that the same treatment can have therapeutic effects on pain and using a validated, well-known pain symptom measurement tool allows one of ordinary skill in the art to compare the efficacy of the collagenase therapy of the claims of ‘138 with other art-known fibroid therapies. Therefore the combination would be desirable because the direct comparison using the same pain measurement scale makes it easier for those in the field to identify the most effective therapies for patients and the most promising potential therapies for further development. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.”
The modification to perform the McGill Pain Scale could be performed with a reasonable expectation of success because it is well known in the art at the time of filing, as evidenced by its use in multiple other fibroid therapy studies. The outcome of observing a reduction of at least 1 point or at least 15 points, as in instant claims 1 and 6, occurs with a reasonable expectation of success because composition disclosed in the claims of ‘138 is identical to the claimed composition because it is a species within the claimed genus and the identical composition is also administered in the same manner and to the same subjects as the claims. Applicant has disclosed in the instant specification that the claimed composition has the claimed functions. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that applying a known technique to a known device, method or product ready for improvement is obvious because a particular known technique is recognized as part of the ordinary capabilities of one skilled in the art. In the instant case, the claims of ‘138 contain a “base” method of treating fibroids, Leppert teaches that this same therapy has effects on fibroid-related pain, and both Feng and Donnez contain a similar method for treating pain associated with fibroids wherein the technique of measuring pain levels with the McGill Pain Scale is taught as advantageous to understand the efficacy of the therapy. Thus, one of ordinary skill in the art would have recognized that applying the known technique taught by Feng and Donnez would have yielded predictable results (i.e. the same advantages) and an improved system.
One of ordinary skill in the art at the time of filing would further consider it prima facie obvious to modify the combination’s method of treating uterine fibroids and their associated pain that measures pain using a scale that is well-known in the field (McGill Pain Scale) by taking the measurement at 60 days following administration, because the art collectively teaches taking measurements for effects within the range of a few months after treatment is administered, and there is no evidence that the 60 day measurement is critical. Instead, it appears to be an arbitrarily chosen time range within the range disclosed in the art as being relevant for measuring symptom changes after a fibroid treatment is applied. MPEP 2144.05 states: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)… A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004). … Applicants can rebut a prima facie case of obviousness by showing the criticality of the range.” Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 10,369,110 in view of Leppert et al. (US-20140271612-A1; hereafter Leppert; cited in IDS filed 10 June 2025), Feng et al. (2010; hereafter Feng; PTO-892), and Donnez et al. (2012; hereafter Donnez; PTO-892).
Regarding claim 1, ‘110 claim 1 (and dependent claims) teaches “A method for the treatment of uterine fibroids in a patient comprising administering into the uterine fibroid a composition comprising an amount of collagenase…” and ‘110 claim 32 (and dependent claims) teaches “A method for the treatment of uterine fibroids in a patient, comprising administering into the uterine fibroid a composition comprising an amount of collagenase…”
Regarding claim 2, ‘110 claims 1, 31-32 teach injection of the composition. Specifically, ‘110 claim 22 teaches “said composition is delivered through a delivery channel into said fibroid, wherein the delivery channel is in a needle, syringe, cannula, catheter or jet injector.”
Regarding claims 3-5, ‘110 claims 1, and 3-4 teach dosages of collagenase that are narrower and thus anticipate at least one of these claims. Specifically, ‘110 claim 1 teaches that the composition can be formulated to provide about 1 mg collagenase per dose administered to 1 cm3 of uterine fibroid tissue, which anticipates all claimed ranges.
As in the rejection of ‘138 above, the claims of ‘110 do not teach that the collagenase treatment has there is a reduction in pain measured on the McGill Pain Scale as measured at 60 days following the administration, as in claims 1, 6, and 8. The claims of ‘110 do not teach that there is a further reduction in one or more symptoms associated with uterine fibroids, as in claim 7. The teachings of the art and the reason for combining is the same as in the rejection of ‘138 above.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,857,685 in view of Leppert et al. (US-20140271612-A1; hereafter Leppert; cited in IDS filed 10 June 2025), Feng et al. (2010; hereafter Feng; PTO-892), and Donnez et al. (2012; hereafter Donnez; PTO-892).
Regarding claim 1, ‘685 claim 1 (and dependent claims) teaches “A method for the treatment of a uterine fibroid in a patient, comprising administering into the uterine fibroid a composition comprising … collagenase…”
Regarding claim 2, ‘685 claims 2 and 7 teach injection of the composition. Specifically, ‘685 claim 2 teaches “said composition is delivered through a delivery channel into said fibroid, wherein the delivery channel is in a needle, syringe, cannula, catheter or jet injector.”
As in the rejection of ‘138 above, the claims of ‘685 do not teach that the collagenase treatment has there is a reduction in pain measured on the McGill Pain Scale as measured at 60 days following the administration, as in claims 1, 6, and 8. The claims of ‘685 do not teach that there is a further reduction in one or more symptoms associated with uterine fibroids, as in claim 7. The teachings of the art and the reason for combining is the same as in the rejection of ‘138 above.
Additionally, the claims of ‘685 do not teach the dosage of collagenase to use, as in claims 3-5. Leppert teaches the claimed dosages, as laid out in the rejection of ‘138 above. One of ordinary skill in the art at the time of filing would consider it prima facie obvious to improve the method of the combination above by using the collagenase dosages disclosed in Leppert, thereby arriving at the claimed invention, because Leppert teaches this dosage is useful for treating uterine fibroids, which is the intended use of the method of the claims of ‘685. Therefore the combination would be desirable because using doses known to be effective would reduce the amount of experimentation needed to practice the claimed invention. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” The dosages could be used with a reasonable expectation of success because injecting the composition at the art-known dosages only requires mixing the composition or performing routine calculations to determine how much of the composition to inject. The outcome of treating uterine fibroids can be performed with a reasonable expectation of success because Leppert teaches the dose is useful and the ’685 claims are not limited to any particular dosage.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that applying a known technique to a known device, method or product ready for improvement is obvious because a particular known technique is recognized as part of the ordinary capabilities of one skilled in the art. In the instant case, the combination contains a “base” method of treating uterine fibroids by applying collagenase; and Leppert contains a similar method for treating uterine fibroids by applying collagenase wherein the technique of using specific dosages of collagenase is taught as advantageous to achieve the therapeutic effect. Thus, one of ordinary skill in the art would have recognized that applying the known technique taught by Leppert would have yielded predictable results (i.e. the same advantages) and an improved system. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/208,183 in view of Leppert et al. (US-20140271612-A1; hereafter Leppert; cited in IDS filed 10 June 2025), Feng et al. (2010; hereafter Feng; PTO-892), and Donnez et al. (2012; hereafter Donnez; PTO-892). This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, ‘183 claim 1 (and dependent claims) teaches “A composition for treating uterine fibroids in a patient comprising:… (b) collagenase.” The product claims anticipate the instant method because they teach administering the same product to the same subject population claimed in the same manner claimed; see MPEP 2112.02: “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.”
Regarding claim 2, ‘183 claims 9-10 teach injection of the composition. Specifically, ‘183 claim 10 teaches the composition “can be administered through a syringe fitted with a 10 gauge or smaller needle…”.
Regarding claims 3-5, ‘183 claims 14-15 teach dosages of collagenase that are narrower and thus anticipate at least one of these claims. Specifically, ‘183 claim 14 teaches that the composition can provide about 0.8 mg collagenase per dose administered to 1 cm3 of uterine fibroid tissue, which anticipates all claimed ranges.
As in the rejection of ‘138 above, the claims of ‘183 do not teach that the collagenase treatment has there is a reduction in pain measured on the McGill Pain Scale as measured at 60 days following the administration, as in claims 1, 6, and 8. The claims of ‘183 do not teach that there is a further reduction in one or more symptoms associated with uterine fibroids, as in claim 7. The teachings of the art and the reason for combining is the same as in the rejection of ‘138 above.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 19/353,950 in view of Leppert et al. (US-20140271612-A1; hereafter Leppert; cited in IDS filed 10 June 2025), Feng et al. (2010; hereafter Feng; PTO-892), and Donnez et al. (2012; hereafter Donnez; PTO-892). This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, ‘950 claim 1 (and dependent claims) teaches “A method for the treatment of uterine fibroids in a patient, the method comprising administering to the uterine fibroid a composition comprising … collagenase…” and ‘950 claim 11 (and dependent claims) teaches “A method for the treatment of uterine fibroids in a patient, the method comprising administering into the uterine fibroid a composition comprising … collagenase…”
Regarding claim 2, ‘950 claims 2 and 12 each teach “said composition is delivered through a delivery channel into said fibroid, wherein the delivery channel is in a needle, syringe, cannula, catheter or jet injector.”
Regarding claims 3-5, ‘950 claims 1 and 4-5 teach dosages of collagenase that are narrower and thus anticipate at least one of these claims. Specifically, ‘950 claim 1 teaches that the composition can provide about 1 mg collagenase per dose administered to 1 cm3 of uterine fibroid tissue, which anticipates all claimed ranges.
As in the rejection of ‘138 above, the claims of ‘950 do not teach that the collagenase treatment has there is a reduction in pain measured on the McGill Pain Scale as measured at 60 days following the administration, as in claims 1, 6, and 8. The claims of ‘950 do not teach that there is a further reduction in one or more symptoms associated with uterine fibroids, as in claim 7. The teachings of the art and the reason for combining is the same as in the rejection of ‘138 above.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/426,567 in view of Leppert et al. (US-20140271612-A1; hereafter Leppert; cited in IDS filed 10 June 2025), Feng et al. (2010; hereafter Feng; PTO-892), and Donnez et al. (2012; hereafter Donnez; PTO-892). This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, ‘567 claim 1 (and dependent claims) teaches “A composition for treating a collagen-mediated disease, comprising collagenase…” including claim 20 which is a kit comprising the composition, ‘567 claim 18 (and dependent claims) teaches “A method for treating a subject suffering from a collagen-mediated disease, comprising administering to said subject the composition of Claim 1 in an amount sufficient to treat said collagen-mediated disease” and ’567 claim 19 teaches the disease can be uterine fibroids. The product claims anticipate the instant method because they teach administering the same product to the same subject population claimed in the same manner claimed; see MPEP 2112.02: “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.”
Regarding claim 2, ‘567 claims 7 teach the composition is injectable and ‘567 claim 8 specifically teaches a syringe and needle.
As in the rejection of ‘685 above, the claims of ‘567 do not teach that the collagenase treatment has there is a reduction in pain measured on the McGill Pain Scale as measured at 60 days following the administration, as in claims 1, 6, and 8. The claims of ‘567 do not teach that there is a further reduction in one or more symptoms associated with uterine fibroids, as in claim 7. Additionally, the claims of ‘567 do not teach the dosage of collagenase to use, as in claims 3-5. The teachings of the art and the reason for combining is the same as in the rejection of ‘685 above.
Conclusion
No claims are allowed.
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AMELIA N DICKENS
Examiner
Art Unit 1645
/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
Prosecution Insights