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 .
DETAILED ACTION
This Office Action is responsive to the Response to Election/Restriction filed 10/21/2025.
Claims 1-28 are pending.
Priority
This application claims the following priority:
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Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 63/081,547 and 63/081,718, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
-‘547 provides support for a method for preventing, treating, or ameliorating radiation proctopathy, proctitis, or pelvic radiation injury, comprising administering an effective dose of at least one acid sphingomyelinase inhibitor tricyclic antidepressant to the rectal tissue of a patient. However, ‘547 does not provide support for a method for treating cutaneous radiation injury or provide support for treatment with any functional inhibitor of acid sphingomyelinase, in general.
-‘718 provides support for a method for preventing treating or ameliorating a dermal condition selected from atopic dermatitis, thermal burn, sunburn, dermatomyo-fibromas, exposure-induced wrinkles, and radiation dermatitis comprising administering a composition comprising a tricyclic antidepressant and/or a SSRI. However, ‘718 does not provide support for a method for treating cutaneous radiation injury, in general, or provide support with an functional inhibitor of acid sphingomyelinase, in general.
As such, the instant application is afforded an effective filing date of 09/22/2021, the filing date of PCT/US2021/051583.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
See, for example, [000160] of the specification.
Election/Restrictions
Applicant’s election without traverse of Group I, the method of treatment, and sertraline as the FIASMA species, and medical radiation treatment as the cutaneous radiation injury, in the reply filed on 10/21/2025, is acknowledged.
Claims 3-4, 7, and 16-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and subject matter, there being no allowable generic or linking claim.
In the course of the search, the cutaneous radiation injury was broadened to include radiation dermatitis.
Claims 1-2, 5-6, and 8-15 are examined on the merits herein.
Claim Objections
Claim 1 is objected to because of the following informalities:
For grammatical clarity, in line 4, “inhibitor” should be replaced with its plural form - -inhibitors- -.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)-Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5-6, and 8-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating cutaneous radiation injury by administering one or more FIASMA, does not reasonably provide enablement for a method for preventing cutaneous radiation injury (see [00071] of the specification and instant claim 2 that defines treating as including preventing) by administering one or more FIASMA. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The criteria for enablement set out in the In re Wands, MPEP 2164.01(a), considers the following factors:
Breadth of the Claims
Independent claim 1 is directed toward a method of treating any cutaneous radiation injury by administering at least one time per day prior to, during or after radiation treatment, 0.5-5 ml of a topical composition comprising an effective amount of any one or more functional inhibitors of acid sphinomyelinase (FIASMA).
As such, the breadth of the claims is great.
Level of Skill in Art
The level of skill in the art is a clinician or a scientist with a PhD.
State of the Prior Art
Shariati (Protective effects of doxepin cream on radiation dermatitis in breast cancer: A single arm double-blind randomized clinical trial, British Pharmacological Society, published 2020, PTO-892) teaches doxepin cream as preventing grade 2 or higher post operative breast irradiation radiation dermatitis, wherein doxepin is a tricyclic antidepressant FIASMA (abstract; pgs. 1878-1879, 3.2; pg. 1879, 4).
Jagetia (Evaluation of the Effect of Ascorbic Acid Treatment on Wound Healing in Mice Exposed to Different Doses of Fractionated Gamma Radiation, Radiation Research, published 2003, PTO-892) teaches that administration of ascorbic acid results in a significant reduction of radiation induced delay in wound healing by increasing collagen content and fibroblast vascular densities (abstract; pg. 371, Introduction).
Thus, the prior art teaches methods of treating injury to the skin by administering a specific active ingredient before or during radiation exposure.
Predictability in the Art
[0006] of the specification teaches that “aloe vera and topical vitamin C have been tried without improvement in the results of irradiated breast tissue.”
[0007] of the specification teaches that while corticosteroids and dexpanthenol-containing emollients can ameliorate radiation dermatitis, they cannot prevent it.
[0009] of the specification teaches that while misoprostol has been found to be an effective radioprotector in animal studies, successful results were not obtained in humans.
[0020] of the specification teaches that there is a lack of available preventive or therapeutic medications for cutaneous radiation injury, including radiation dermatitis, and that it is a longstanding unmet patient need affecting millions of patients.
As such, the art of treating and preventing cutaneous radiation injury is unpredictable.
Working Examples
Examples 1-2 are prophetic examples.
Example 3, beginning on pg. 42, is directed toward the treatment of radiation dermatitis in radiated mice by administering a sertraline composition beginning two days prior to irradiation, and shows that application of the composition improves radiation dermatitis.
Example 4, beginning on pg. 47, is directed toward the treatment of radiation dermatitis in radiated mice by administering a sertraline composition beginning two days starting 24 hours after irradiation, and shows that application of the composition improves radiation dermatitis.
Thus, the instant examples provide support for a method of treating radiation dermatitis by administering sertraline prior to or after radiation treatment.
Direction and Guidance
In view of the large breadth of the claims in comparison to the limited scope of the working examples, the teachings of the prior art, and the unpredictability of the art, the instant specification lacks sufficient direction and guidance to use the method as instantly claimed.
Quantity of Experimentation
The amount of experimentation required to determine which cutaneous radiation injury can be prevented with which FIASMA, administered either before, during, or after radiation treatment, would be astronomical. This amounts to invention and not development; it is an undue amount of experimentation.
Thus, while being enabling for a method of treating cutaneous radiation injury by administering one or more FIASMA, the specification does not reasonably provide enablement for a method for preventing cutaneous radiation injury (see [00071]) by administering one or more FIASMA.
Claim Rejections - 35 USC § 112(b)
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 14-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites the limitation "the effective dose" in line 2. There is insufficient antecedent basis for this limitation in the claim. While claim 1 recites “an effective amount,” this phrase does not provide antecedent basis for “the effective dose.”
Claim 15 recites the limitation "the active ingredient" in line 2. There is insufficient antecedent basis for this limitation in the claim. While claim 1 recites “one or more functional inhibitor of acid sphingomyelinase,” this phrase does not provide antecedent basis for “the active ingredient.”
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 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 1-2, 5-6, 8, 11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Shariati (Protective effects of doxepin cream on radiation dermatitis in breast cancer: A single arm double-blind randomized clinical trial, British Pharmacological Society, published 2020, PTO-892).
Shariati teaches doxepin cream as preventing grade 2 or higher post operative breast irradiation radiation dermatitis (abstract; pgs. 1878-1879, 3.2; pg. 1879, 4). Dermatitis caused by radiation is a side-effect of radiotherapy for breast cancer. Radiation injures keratinocytes, resulting in oxidative stress form the production of reactive oxygen species associated with tissue damage (pg. 1879, Col. 1).
As evidenced by [00024], [00056], and [00079] of the instant specification, doxepin is a tricyclic antidepressant FIASMA (abstract).
Shariati specifically teaches a doxepin cream (5%), wherein each gram of the doxepin contains 50 mg doxepin hydrochloride (pg. 1877, 2.4). Shariati teaches beginning administration of this cream starting from the last week of radiotherapy, wherein it is administered three times per day on the affected areas (pg. 1877, 2.5).
Regarding claims 1-2, 5-6, 8, and 14-15, while Shariati teaches a method of treating radiation dermatitis caused by breast cancer irradiation, by administering a cream comprising doxepin three times per day, it differs from that of instant claims in that it does not teach administering 0.5-5ml of the composition.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select administration of 0.5-5ml of the doxepin cream of Shariati, to arrive at instant claims 1-2, 5-6, 8, and 14-15. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Shariati teaches administering an amount to treat radiation dermatitis and specifically teaches a doxepin cream (5%) dissolved in glyceryl stearate and 100 g cold cream, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at the most therapeutically effective amount of doxepin to treat radiation dermatitis.
Regarding claim 11, Shariati teaches that 1 gram of the cream comprises 50mg doxepin hydrochloride or 44.3 mg of doxepin (pg. 1877, 2.4).
Claims 9-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Shariati (Protective effects of doxepin cream on radiation dermatitis in breast cancer: A single arm double-blind randomized clinical trial, British Pharmacological Society, published 2020, PTO-892), as applied to claims 1-2, 5-6, 8, 11, and 14-15 above, and further in view of Kornhuber (Identification of New Functional Inhibitors of Acid Sphingomyelinase Using a Structure-Property-Activity Relation Model, J. Med Chem, published 2008, PTO-892).
Shariati is applied as discussed above and incorporated herein.
Regarding claims 9-10, while Shariati teaches a method of treating radiation dermatitis caused by breast cancer irradiation, by administering a cream comprising doxepin three times per day, it differs from that of instant claims 9-10 in that it does not teach sertraline.
Kornhuber teaches inhibitors of acid sphingomyelinase (title, abstract).
Kornhuber teaches doxepin and sertraline as functional ASM inhibitors, which are minimally toxic and rapidly available (abstract; paragraphs spanning pgs. 219-220; pg. 227, Col. 2; pg. 231).
Kornhuber teaches agents that reduce ASM and ceramide levels as attenuating apoptosis and promoting cell proliferation, thus having antiapoptotic and neuroprotective effects. Kornhuber teaches these compounds for use in radiation induced apoptosis (pg. 228, Col. 2).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the doxepin of Shariati with sertraline, to arrive at instant claims 9-10. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Kornhuber teaches both doxepin and sertraline as functional ASM inhibitors,
-Kornhuber teaches these compounds for use in radiation induced apoptosis, and
-substituting equivalents known for the same purpose is prima facie obvious, see MPEP 2144.06.
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at a method of treating radiation dermatitis by attenuating apoptosis and promoting cell proliferation.
Regarding claim 12, while the combination of Shariati and Kornhuber teaches a method of treating radiation dermatitis caused by breast cancer irradiation, by administering a cream comprising sertraline, it differs from that of instant claim 12 in that it does not teach up to 40 mg sertraline per ml of the composition.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select administration of up to 40 mg sertraline per ml of the composition, to arrive at instant claim 12. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-the combination of Shariati and Kornhuber are directed toward a method of treating radiation dermatitis by administering an effective amount of sertraline, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at the most therapeutically effect method of administering sertraline to treat radiation dermatitis due to breast cancer irradiation.
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Shariati (Protective effects of doxepin cream on radiation dermatitis in breast cancer: A single arm double-blind randomized clinical trial, British Pharmacological Society, published 2020, PTO-892), as applied to claims 1-2, 5-6, 8, 11, and 14-15 above, and further in view of Jagetia (Evaluation of the Effect of Ascorbic Acid Treatment on Wound Healing in Mice Exposed to Different Doses of Fractionated Gamma Radiation, Radiation Research, published 2003, PTO-892)
Shariati is applied as discussed above and incorporated herein.
Regarding claim 13, while Shariati teaches a method of treating radiation dermatitis caused by breast cancer irradiation, by administering a cream comprising doxepin three times per day, it differs from that of instant claim 13 in that it does not teach the composition as further comprising an antioxidant.
Jagetia teaches that ionizing radiation, although a useful modality for cancer treatment, produces detrimental local effects on tissues, including an impairment of wound healing, and further teaches ascorbic acid as a known radioprotective agent (pg. 375, 1st full paragraph).
Jagetia specifically teaches that administration of ascorbic acid results in a significant reduction of radiation induced delay in wound healing by increasing collagen content and fibroblast vascular densities (abstract; pg. 371, Introduction).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add ascorbic acid, i.e., vitamin C, to the composition comprising doxepin of Shariati, to arrive at instant claim 13. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-both Shariati and Jagetia are directed toward a method of treating skin injury due to cancer radiation,
-Jagetia teaches ascorbic acid as improving wound healing by increasing collagen content and fibroblast and vascular densities, and
-"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
As such, an ordinary skilled artisan would have been motivated to make such an addition, to predictably arrive at a more therapeutically effective/potent method of treating radiation dermatitis.
Non-Statutory 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 1-2, 5, 6, and 8-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,179,353 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘353 claim a method for treating or ameliorating radiation dermatitis by topically administering to a target area of skin, to a patient, at least one time per day prior to, during, or after radiation treatment, 0.5-5ml of a composition consisting of 5-50 mg/ml sertraline and one or more pharmaceutically acceptable excipients (claim 1).
‘353 claims vitamins A, C, D, or E as excipients (claim 3).
‘353 claims the composition in the form of lotion, cream ointment, or gel (claim 4).
Claims 1-2, 5, 6, and 8-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,173,111 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘111 claims a method for treating or ameliorating radiation proctopathy by topically, daily administering to the rectum, a composition consisting of 1-100mg sertraline and pharmaceutically acceptable excipient per 1ml of composition (claim 1).
‘111 claims a method for treating or ameliorating radiation proctopathy by topically, daily administering to the rectum, a composition consisting of 1-100mg sertraline, a second active ingredient, and a pharmaceutically acceptable excipient per 1ml of composition, wherein vitamins A, C, D, or E are the second active ingredients (claim 8).
‘111 claims 50mg as the effective dose of sertraline (claim 7).
‘111 claims the composition in the form of lotion, cream ointment, or gel (claim 3).
Claims 1-2, 5-6, 8-9, 11, and 14-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10-19 of copending Application No. 19/087,474 (claim set dated 03/22/2025, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘474 claims:
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‘474 claims the composition in the form of a topical cream, gel, or ointment (claim 7).
‘474 claims administration of 1-100mg/ml of an SSRI (claim 19).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 10 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10-19 of copending Application No. 19/087,474 (claim set dated 03/22/2025, reference application), as applied to claims 1-2, 5-6, 8-9, 11, and 14-15, and further in view of Kornhuber (Identification of New Functional Inhibitors of Acid Sphingomyelinase Using a Structure-Property-Activity Relation Model, J. Med Chem, published 2008, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘474 and Kornhuber are applied as discussed above.
Regarding instant claims 10 and 12, while ‘474 teaches administration of an SSRI, it differs from that of the instant claims 10 and 12 in that it does not teach sertraline.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select sertraline as the SSRI of ‘474. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘474 teaches SSRI claims its compositions as comprising SSRIs that are functional ASM inhibitors,
-Kornhuber teaches sertraline, a SSRI, as a functional ASM inhibitors,
-Kornhuber teaches these compounds for use in radiation induced apoptosis, and
-substituting equivalents known for the same purpose is prima facie obvious, see MPEP 2144.06.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at an SSRI that is effective for treating radiation dermatitis by inhibiting the ASM pathway.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 12, the optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Conclusion
No claims are allowed.
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/LAUREN WELLS/Examiner, Art Unit 1622