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 1-5 are presented for examination on the merits.
Note on claim interpretation: the term Locomotive syndrome is taken as meaning a condition of reduced mobility due to impairment of locomotive organs. Since upright bipedal walking involves minutely controlled movement patterns, impairment of any aspect of the locomotive organs has the potential to adversely affect it. In addition to trauma, chronic diseases of the locomotive organs, which progress with repeated bouts of acute exacerbations, are common causes of the locomotive syndrome. The three main components comprising the locomotive system are bones (support), joints and intervertebral disks (mobility, impact absorption) and the muscular and nervous system (drive, control) [36, 37]. Any impairment in these organs results in pain, limited range of motion at joints or at the spine, muscle weakness and balance deficits. All these impairments are inter-related and serve as multiple risk factors for disability. Common Locomotive Organ Diseases include chronic diseases such as disk degeneration and lower extremity cartilage degeneration. Among the traumatic causes, fractures of the proximal femur, which too are related to osteoporosis, are the most common. (see Nakamura et al. (2016).
Thus the definition of Locomotive Syndrome is quite broad and any treatment that would improve chronic diseases of the locomotive organs, bone resorption, osteoporosis, muscular and nervous system infirmities would treat Locomotive Syndrome.
Claim Rejections - 35 USC § 112
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 1-5 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 locomotive syndrome with phycocyanin or an aqueous extract of spirulina containing such, does not reasonably provide enablement for preventing or ameloriating locomotive syndrome with spirulina and/or phycocyanin. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
See Genentech v. Novo Nordisk, 108 F. 3d 1361, 1366 “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. See Brenner v. Manson, 383 U.S. 519, 536, 86 S. Ct. 1033, 1042-43, 16 L. Ed. 2d 69, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.”
In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970), held that "Inventor should be allowed to dominate future patentable inventions of others where those inventions were based in some way on his teachings, since such improvements while unobvious from his teachings, are still within his contribution, since improvement was made possible by his work; however, he must not be permitted to achieve this dominance by claims which are insufficiently supported and, hence, not in compliance with first paragraph of 35 U.S.C. 112; that paragraph requires that scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific law; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved."
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples provided in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8USPQ2d 1400, 1404 (Fed. Cir. 1988).
With respect to the Wands factors (particular as they pertain to the quantity of experimentation necessary as well as the state of the prior art within the medical field), Applicants have reasonably demonstrated/disclosed that hot water extracts of spirulina containing the active ingredient phycocyanin could possibly attenuate locomotive syndrome. However, the claims also encompass using the claimed compound to prevent locomotive syndrome which is clearly beyond the scope of the instantly disclosed/claimed invention. Please note that the term "prevent" is an absolute definition which means to stop from occurring and, thus, requires a higher standard for enablement than does "treat", especially since it is notoriously well accepted in the medical art that the vast majority of afflictions/disorders suffered by mankind cannot be totally prevented with current therapies - including preventing such disorders as locomotive syndrome (which clearly is not recognized in the medical art as being a totally preventable condition).
Applicant’s claims are drawn to treatment of locomotive syndrome, which has a very broad meaning (see above) by administration of spirulina or phycocyanin. However, the specification provides only one working example, with the results featured in Table 1, wherein spirulina and phycocyanin were recognized to exert the effect on the joint and the mobility ameliorating effect. On the other hand, the composition in Comparative Example 1 was recognized to exert the effect on the joint, but was not recognized to exert the mobility ameliorating effect.
Regarding the extraction solvent used to obtain the product with the functionality claimed, it is well known in the art that polarity of solvents plays a key role in determining the final product obtained by an extraction. However, because many phytochemicals remain undiscovered, the skilled artisan has to make his/her best educated guess as to what types of phytochemicals will be successfully extracted with a solvent of a particular polarity. Oftentimes, unless the constituents in a particular natural product extract have been well evaluated and documented in the literature, the skilled artisan must adhere to trial and error protocols in order to quantitatively determine phytochemical constituents present in samples obtained from respective extraction procedures. These procedures are common when, for example, a natural product or part thereof has been documented in the literature as possessing some medicinal quality. The skilled artisan will attempt numerous extraction protocols in an attempt to isolate particular ingredient(s) that have medicinal efficacy. Typically, beginning with the first crude extraction, it is a guess as to whether or not the extract will possess certain phytochemical constituents. For example, unpredictability with regard to natural extracts due to their highly complex nature has been well documented. Revilla et al. (J. Agric. Food Chem. (1998), vol. 46, pp. 4592-4597) showed that the slightest variations in polarity of solvent and reaction time upon grape extraction provided respective products with unique characteristic properties (See tables 1, 2, 4, 5, 6 and 7 in Revilla). In turn, each product would possess varying pharmacological properties based upon their respective methods of extraction.
There is well-known unpredictability regarding natural product extracts and their e.g., pharmaceutical capabilities. The resulting compositions and thus functional properties of an extraction process are highly dependent on the particular steps of the extraction and the extraction solvent employed
Raskin et al. clearly establish the grave unpredictability of elucidating active ingredients from natural sources:
Multi-component botanical therapeutics also present unique challenges in identifying their active ingredients and in validating their clinical effects. Activity-guided fractionation and reconstitution experiments currently used to characterize compound interferences within a mixture are cumbersome and time consuming…..While chromatographic analysis is often employed to produce biochemical fingerprints used for product comparison…..in the absence of information about the identity of active ingredients, such analysis is hardly reliable, since chromatography provides an incomplete picture of the qualitative and quantitative comparison of a complex extract (p. 3426, col. 2 – p. 3427, col. 1) emphasis added.
Thus, the functional property of an botanical extract such as spirulina is not considered to be predictable because the type of extraction used to produce the extract would have a significant impact on the chemical characteristics of the extract.
The specification does not provide any specific guidance to show that any and all spirulina (or extracts thereof) have the claimed functionality. An artisan would have to test every potential extraction technique with the virtually limitless number of solvents as well as every in order to determine if it is able to improve locomotion. This degree of experimentation clearly places an undue burden on the artisan of ordinary skill. Consequently, given the unpredictability of the art, the lack of guidance from the specification and the quantity of experimentation needed to practice the claimed invention, the claims are not considered to be enabled for every spirulina (or extract thereof) that may have the ability improve locomotion.
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.
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.
Claim(s) 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Tagagaki (JP2007/99664) {cited by Applicant in IDS filed 2/7/24}.
Tagagaki beneficially discloses a food product that contains a bone resorption inhibitor comprising processed kale, a soybean germ extract, and spirulina. The reference also indicates that bone breakage can be inhibited by using the aforementioned inhibitor, and discloses collagen, hyaluronic acid, acetyl glucosamine, and the like as components that can be added. Inhibiting bone breakage can be said to play a role in preventing osteoporosis and to have an effect for suppressing any reduction in movement functions (see entire document, including e.g., claims 1 and 2 and paragraphs [0053], [0065]).
Claim(s) 1, 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Coxam et al. (US2021/0077574).
Coxam et al. beneficially teach a phycocyanin composition, for use in inhibiting bone resorption in humans or animals. In certain embodiments, said composition is a nutritional composition suitable for oral administration. Advantageously, said nutritional composition aims to prevent bone loss, also called osteopenia, in particular in individuals in whom the occurrence of bone loss may be expected, for example on account of age or else bone loss that is likely to occur owing to other factors, for example such as taking medicinal products.
While the cited references do not explicitly disclose the results of the recited step of administering sprirulina or phycocyanin, such a result is a necessary consequence of said positively recited step of the method and thus does not effectively limit the claimed method (see e.g., Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F. 3d 1373 (Fed. Cir. 2003) (a “clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”).
Thus, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the instant Application to administer spirulina to improve mobility and thus effectively treat Locomotive Syndrome as taught by the prior art such as Tagagaki et al. and Coxam et al.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
The adjustment of particular conventional working conditions (e.g., determining an appropriate daily dose thereof and/or employing one or more commonly-employed excipients or known means of administration, etc.) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Accordingly, the instant claims, where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 5712720947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RUSSELL G FIEBIG/Examiner, Art Unit 1655