DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 2-10 are under examination.
Response to Applicants Amendments/Remarks
The examiner has carefully considered applicant’s arguments and recent amendments. The claims have been amended to state that the active ingredient consists of melatonin. This significantly changes the scope of the invention. The examiner has withdrawn the rejections presented in the previous office action and is now putting forward new rejections.
Response to Applicants Instant Set of Claims
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2,4-6,8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Escames Rosa (USPT 8,962,673) in view of Kanwar (US 20110182943). Escames Rosa and Kanwar are already of record. Escames Rosa was cited on PTO-892 (11/25/2022), and Kanwar was cited on PTO-892 (6/26/2023).
Escames Rosa teaches a method for reducing radiation injury in a subject (Abstract of Escames Rosa) comprising: selecting a subject that will receive radiotherapy (Abstract of Escames Rosa), and topically administering (Column 7 of Escames Rosa) a composition comprising an effective amount of an active ingredient, which reduces radiation injury (Abstract and Column 5, lines 18-44 of Escames Rosa), wherein the active ingredient consists of melatonin (Column 2, line 49-65) to the epithelium of the subject (Column 7), wherein a single dose of the composition is topically administered to the subject (Column 7) as in instant Claims 2 and 10.
Escames Rosa teaches that its melatonin composition can be used to treat “mucositis.” In the Escames Rosa reference, mucositis refers to “a disease occurring with inflammation of the mucosae of the gastrointestinal tract, i.e. oral, pharyngeal, esophageal, stomach, and intestinal mucosa, and it is characterized by having an impact on mucosa integrity and function that can lead to ulceration.” The mucositis is caused by radiation. (Column 5, lines 19-27 of Escames Rosa). Escames Rosa teaches that the composition can be applied to the mucosae associated with the gastrointestinal tract. Escames Rosa does not teach that the mucositis treated is located in the mucosae of the vagina. It would have been obvious to an artisan of ordinary skill at the time of effective filing to have treated vaginal mucositis with Escames Rosa’s composition containing melatonin. An artisan would have been motivated to have treated vaginal mucositis with Escames Rosa’s melatonin composition because Escames Rosa teaches that a melatonin composition can treat mucositis present in multiple regions of the body (oral, pharyngeal, esophageal, stomach, intestine---Column 5, lines 45-48). There would have been motivation for treating the mucus membranes in the vagina with Escames Rosa’s composition since the melatonin composition of Escames Rosa has already been shown to treat different types of mucous membranes located in different regions of the body (Column 5, lines 45-48 of Escames Rosa) and provide protection from radiotherapy (Abstract of Escames Rosa). Furthermore, Kanwar teaches that vaginal mucosa can be treated with a topical composition containing melatonin (Paragraphs 132,204, and 334 of Kanwar). Kanwar’s composition is used to treat cancers and/or the unwanted side-effects of cancer therapies such as radiotherapy (Paragraphs 6, 132, and 334 of Kanwar). Because melatonin can successfully treat mucositis caused by radiotherapy, there would have been a high expectation for success (Abstract and Column 5 of Escames Rosa) as in instant Claims 2 and 10.
Escames Rosa teaches, “A topical application was applied…before irradiation, another one after, and successive application were applied every 8 hours for 21 days (Column 11, lines 29-31).” Escames Rosa teaches that the product can be applied before irradiation or after irradiation. Escames does not provide the more specific periods of administration recited in the claims. However, MPEP § 2144.05 (II) states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In reHoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
A review of the specification fails to provide evidence that the claimed frequency of administration which would affect characteristics such as concentrations are critical. Absent such evidence it would have been obvious to an artisan of ordinary skill at the time of effectively filing Escames Rosa to try a finite type of administration frequences/concentration amounts because determining the time period of administration of a melatonin and composition concentration were long established in the art as demonstrated by Escames Rosa. Thus, Escames Rosa renders the instantly claimed frequency of administration above as recited in claims 2,4-5,9-10.
Dependent Claims taught by Escames Rosa
Escames Rosa teaches that a dose of melatonin is 2.5 to 5 grams (Column 3, lines 4-9) as in instant Claim 6. Escames Rosa teaches wherein the composition is administered in in the form of a foam, gel, cream, or ointment (Column 7, lines 40-45) as in instant claim 8.
Dependent Claims taught by Kanwar
Kanwar teaches that administration can be at least daily (at least once a day) and topically administered (Paragraphs 42,75, and 210 of Kanwar) as in instant Claim 4. Kanwar teaches topically administering the formulation over a period of up to 3 months or more (Paragraphs 73-74 of Kanwar) as in instant Claim 5. Kanwar teaches topical formulations may be prepared as lotions, creams, ointments, pastes, and salves (Paragraphs 195 of Kanwar) as in instant Claim 8. Kanwar teaches that the treatment regime is continuous (Paragraph 75 of Kanwar) as in instant Claim 9.
Escames Rosa teaches that mucositis caused by irradiation located in different regions of the body can be treated with its composition containing melatonin. However, Escames Rosa does not specifically state that its composition can be used to treat a vaginal mucus membrane. However, an artisan would have been motivated to have used Escames Rosa’s melatonin composition to treat vaginal mucus membranes since the melatonin composition of Escames Rosa is known to treat mucus membranes in multiple different regions of the body (oral, pharyngeal, esophageal, stomach, or intestine). Furthermore, Kanwar has also revealed that melatonin can be topically applied to treat vaginal regions/vaginal mucus membranes impacted by cancer and/or the therapies applied to treat cancer. Given the teachings of the cited references and the level of skill of an artisan at the time of applicant’s invention, it must be considered absent evidence to the contrary, that the ordinarily skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. V. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cancer, therapy, and cell culture.
Claims 2-10 are rejected under 35 U.S.C. 103 as being unpatentable over Escames Rosa (USPT 8,962,673) in view of Kanwar (US 20110182943) and Giancarol (WO 99/47175)
Escames Rosa and Kanwar apply as above to teach claims 2,4-6,8-10. Escames Rosa applies as above to teach the frequency of administration/concentration as discussed above in the optimization argument as in instant Claim 7. Escames Rosa does not teach that its formulation can be delivered to the body in a vaginal suppository form. However, Giancarol teaches that melatonin can be delivered to the body in a form of a suppository (Claim 9; Page 5, ln 7 of Giancarol). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used a suppository form to deliver the medicament. An artisan would have been motivated to have used a suppository form of melatonin (claim 9 of Giancarol) since it can be used to successfully deliver melatonin to a region of the body including a vagina (Page 4, ln 29 of Giancarol). Because suppositories can be used to successfully deliver melatonin to the body, there would have been a high expectation for success as in instant Claims 3 and 7.
Escames Rosa teaches that mucositis can be treated with a composition containing melatonin. Escames Rosa teaches that its melatonin containing composition can be used to treat many different regions containing a mucus membrane damaged by irradiation. However, Escames Rosa does not specifically state that its composition can be used to treat a vaginal mucus membrane. However, an artisan would have been motivated to have used Escames Rosa’s melatonin composition to treat vaginal mucus membranes since the melatonin composition of Escames Rosa is known to treat mucus membranes in multiple different regions of the body (oral, pharyngeal, esophageal, stomach, or intestine) successfully. Furthermore, Kanwar has also revealed that melatonin can be topically applied to treat vaginal regions negatively impacted by cancer/cancer therapies. Giancarol teaches that compositions such as melatonin can be delivered to the body using suppositories. Given the teachings of the cited references and the level of skill of an artisan at the time of applicant’s invention, it must be considered absent evidence to the contrary, that the ordinarily skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. V. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cancer, therapy, and cell culture.
Conclusion
All claims stand rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638