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 .
Claim Status
Applicants' response and amendments to the claims, filed 08/27/2025, are acknowledged and entered. Claim 6 has been cancelled and claims 12-20 newly added by Applicant.
Claims 1-5 and 7-20 are pending and under examination.
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.
"The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claim 4 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation “more preferably”. This renders the claim indefinite as to what preference results in the “more preferably” limitation and whether the limitation following the recited “more preferably” is intended to limit the scope of the claim. Specifically, claim 4 recites citrus flavonoid is present in an amount in the range from 30 to 100 mg, “more preferably in an amount of about 53.3 mg”, which renders the claim unclear what amount of citrus flavonoid is actually required to be present, e.g., whether the claim is limited to only the “more preferably” amount of 53.3 mg.
Response to Arguments
While Applicant amended to claim 4 to remove recitation of “preferably”, the claim still recites the limitation “more preferably in an amount of about 53.3 mg”.
Claim Rejections - 35 USC § 112(a) (Enablement)
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-5 and 7-20 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 treating one or more menstrual disorders selected from the group consisting of Dysmenorrhea and Premenstrual Syndrome (PMS) comprising orally administering a composition comprising from 2 to 10 mg Vitamin D3, from 1 mg to 4 mg lycopene, from 30 mg to 100 mg citrus flavonoid, from 0.1 mg to 0.8 mg astaxanthin, from 200 mg to 300 mg calcium carbonate, and from 80 mg to 400 mg calcium lactate, does not reasonably provide enablement for treating one or more menstrual disorders selected from the group consisting of Dysmenorrhea and Premenstrual Syndrome (PMS) comprising administering a composition comprising other amounts of other Vitamin D3, other amounts of citrus flavonoids, other amounts of astaxanthin, and other amounts of calcium carbonate, and other amount of calcium lactate. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, and breadth of the claims
The invention is drawn to a method of treating one or more menstrual disorders selected from the group consisting of Dysmenorrhea and Premenstrual Syndrome (PMS) comprising administering a composition comprising Vitamin D3, lycopene, citrus flavonoid, astaxanthin, calcium carbonate, and calcium lactate.
Independent claim 1 does not recite or require any particular amounts of any of the claimed active agents, let alone therapeutically effective amounts. Indeed, the claim encompass embodiments where only nominal amounts of one or all of the recited ingredients are present, e.g., 0.000001 mg of lycopene.
The claims are extremely and indeterminately broad, especially in view of the very narrow guidance and direction provided by Applicant. As broadly encompassed by the claims, the following distinct and diverse compositions are encompassed by the claims and hypothesized by Applicant to have the same therapeutic activity:
Vitamin D3 100 mg
Calcium carbonate 10 mg
Calcium lactate 1 g
Lycopene 0.00001 mg
Astaxanthin 500 mg
Citrus flavonoids 1 g
Vitamin D3 0.00001 mg
Calcium carbonate 0.00001 mg
Calcium lactate 0.00001 mg
Lycopene 50 mg
Astaxanthin 10 mg
Citrus flavonoids 10 mg
These factors weight against enablement for the full scope of the claimed invention.
The state and predictability of the art, and relative skill of those in the art
A person of ordinary skill in the art would not be able to reasonably predict what compositions comprising Vitamin D3, lycopene, citrus flavonoid, astaxanthin, calcium carbonate, and calcium lactate in what amounts and administered by what routes of administration will have therapeutic efficacy in treating one or more menstrual disorders selected from the group consisting of Dysmenorrhea and Premenstrual Syndrome (PMS).
The treatment of one or more menstrual disorders selected from the group consisting of Dysmenorrhea and Premenstrual Syndrome (PMS) with compositions comprising Vitamin D3, lycopene, citrus flavonoid, astaxanthin, calcium carbonate, and calcium lactate generally is not considered enabled.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. That factor is outweighed, however, by the unpredictable nature of the art.
It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.), Nationwide Chemical Corporation, et al. v. Wright, et al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances), Ex parte Sudilovsky 21 USPQ 2d 1702 (Appellant's invention concerns pharmaceutical activity. Because there is no evidence of record of analogous activity for similar compounds, the art is relatively unpredictable) In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian recombinant virus vaccine was uncertain). As long as the Specification discloses at least one method of making and using the claimed invention that bears a reasonable correlation to the entire scope of the claim, then the enablement requirement of 35 U.S.C. 112, 1st Paragraph is satisfied. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). To that extent, if little is known in the prior art about the nature of the invention and the art is unpredictable, the Specification would need more detail as to how to make and use the invention in order to be enabling. See Chiron Corp v. Genetech, lnc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) ("Nascent technology, however, must be enabled with a specific and useful teaching. The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee's instruction. Thus, the public's end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology.")
Here, Applicant fails to disclose at least one method of making and using the claimed invention that bears any reasonable correlation to the entire scope of the claim. Indeed, Applicant discloses only a single, specific formulation comprising:
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Working backwards from this single formulation, Applicant now claims any composition comprising Vitamin D3, lycopene, citrus flavonoid, astaxanthin, calcium carbonate, and calcium lactate in any amounts whatsoever and administered by any routes of administration, will be therapeutically effective to treat one or more menstrual disorders selected from the group consisting of Dysmenorrhea and Premenstrual Syndrome (PMS).
These factors weigh against enablement for the full scope of the claimed invention.
The amount of direction or guidance provided and the presence or absence of working examples
The specification provides direction or guidance for making and using a single composition having specific amounts of specific active ingredients. See Examples.
Indeed, working examples are limited to orally administering capsules comprising:
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The capsules were administered to women presenting with Dysmenorrhea (Example 2), Premenstrual Syndrome (Example 3), or Dysmenorrhea and Premenstrual Syndrome (Example 4).
These factors weigh against enablement for the full scope of the claimed invention.
The quantity of experimentation necessary
Because of the known unpredictability of the art (as discussed supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept the assertion that compositions comprising Vitamin D3, lycopene, citrus flavonoid, astaxanthin, calcium carbonate, and calcium lactate generally could be predictably used as a treatment for one or more menstrual disorders selected from the group consisting of Dysmenorrhea and Premenstrual Syndrome (PMS) as inferred in the claims and contemplated by the specification.
Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and ‘patent protection’ is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable” (42 USPQ 2d 1001, Fed. Circuit 1997).
In the instant case, Applicant has presented a general idea that because a single, specific composition comprising 4 mg Vitamin D3, 262 mg calcium carbonate, 179 mg calcium lactate, 1.6 mg lycopene, 0.4 mg astaxanthin, and 53.3 mg citrus flavonoids orally administered to women was effective to treat Dysmenorrhea and/or Premenstrual Syndrome, then any composition comprising Vitamin D3, lycopene, citrus flavonoid, astaxanthin, calcium carbonate, and calcium lactate in any amounts and administered by any route of administration, must therefore, a priori, also be useful in the treatment of Dysmenorrhea and/or Premenstrual Syndrome. However, the claims place with no limitations whatsoever on their amounts except in dependent claims and even here such claims only further limit each ingredient individually. A person of ordinary skill in the art would be tasked with figuring out, through random hit-or-miss testing, what amounts of each of Vitamin D3, lycopene, citrus flavonoid, astaxanthin, calcium carbonate, and calcium lactate in combination are actually therapeutically effective to treat Dysmenorrhea and/or Premenstrual Syndrome when administered by any given route of administration. Given the fact that Applicant provides no pre-clinical models for such testing, human clinical trials would be required. This is undue experimentation given the very narrow, limited guidance and direction provided by Applicant and the vast scope of the claims.
Accordingly, determining if any particular claimed combination of Vitamin D3, lycopene, citrus flavonoid, astaxanthin, calcium carbonate, and calcium lactate in any particular amounts would be effective treat Dysmenorrhea and/or Premenstrual Syndrome by administration by any particular route of administration would require formulation of the composition into a suitable dosage form and subjecting it to clinical trials in women having Dysmenorrhea and/or Premenstrual Syndrome. This is undue experimentation given the vast scope of the claims, the state and predictability of the art, the very narrow, limited guidance and direction provided by Applicant, and the fact that only a single, specific composition was made and tested by Applicant.
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. § 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Response to Arguments
Applicants argue:
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In response, there is no single claim, either independent or dependent, that places limitations on the amounts of all of the recited components. Claim 1 does not even recite administering a “therapeutically effective amount”. Rather, as discussed above, the claims encompass only nominal amounts of any one or more of the recited components which a person of ordinary skill in the art would not predict to be at all therapeutically effective. For example, it is unclear if it is Applicant’s contention that administering a composition comprising 0.00001 mg Vitamin D3, 0.00001 mg lycopene, 0.00001 mg citrus flavonoids, 0.00001 mg astaxanthin, 0.00001 mg calcium carbonate, and 0.00001 mg calcium lactate will be effective to treat one or more menstrual disorders simply because some amount of each component is present. This is not at all believable.
Applicant argues:
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The Examiner never suggested that claim 1 be restricted to “specific amounts” as asserted by Applicant. The Examiner rather requires that the claims be limited to disclosed ranges of each recited component which certainly allows for the adjustment of amounts of each component for formulative purposes. Applicant is certainly not entitled to patent protection for amounts of the claimed components that are not even disclosed by Applicant.
Applicant cites to post-filing art (Cornelli et al.) as evidence the disclosure is enabled. In response, the Specification mist be enabling as of the filing date. The state of the art existing at the filing date of the application is used to determine whether a particular disclosure is enabling as of the filing date. Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004) (Stating that "a patent document cannot enable technology that arises after the date of application."). Information published for the first time after the filing date generally cannot be used to show what was known at the time of filing. In re Gunn, 537 F.2d 1123, 1128, 190 USPQ 402,405-06 (CCPA 1976) MPEP 2164.05(a). That amounts outside of the disclosed ranges were later found to be effective is immaterial to the rejection because this information was not available or known to those skilled in the art when the application was filed.
Conclusion
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.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 8:30 am - 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
400 Dulany Street
Alexandria, VA 22314-5774
Tel. No.: (571) 272-9038
1 As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.