DETAILED ACTION
Status of Claims
Claims 1-8 are currently pending. Claims 1-4 and 8 are currently under consideration and are the subject of this Office Action. This is the first Office Action on the merits of the claims. Non-elected claims 5-7 are withdrawn from consideration. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Office Action: Non-Final.
Election/Restrictions
Applicant’s election of the claims of Group I (claims 1-4 and 8) in the response filed on November 11, 2025 (to the September 17, 2025 Requirement for Restriction) is acknowledged. In response to applicant’s election, the claims of Group II (claim 5) and Group III (claims 6-7) are withdrawn from further consideration pursuant to 37 C.F.R. § 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant has elected the claims of Group I with traverse.
The traverse is based on applicant’s argument:
Traversal of the Restriction Requirement
Applicant traverses the restriction requirement on the grounds that the groups identified by the Examiner are not independent or distinct inventions for the following reasons:[Remarks, p. 7, par. 7]
The Claims Share a Common Core Invention
The product (Group I), the preparation method (Group II), and the method of use (Group III) all revolve around the same inventive concept: a formula comprising tea and sodium chloride. The preparation and use claims are inherently tied to the composition and properties of the product, and thus do not represent separate inventions.[Remarks, p. 7, par. 8, cont. on p. 8]
No Materially Different Product or Process Exists
The Examiner' s assertion that the claimed product could be used in unrelated fields (e.g., as a fabric dye or in vitro separation agent) is speculative and not supported by the specification. The claimed invention is directed specifically to a formula for inhibiting aging and promoting regeneration and repair. Any alternative uses are not material to the claimed invention and do not justify restriction.[Remarks, p. 8, par. 1]
No Serious Search or Examination Burden Exists
The fields of search for all groups are closely related, and the same prior art would likely be relevant to all groups. The classifications cited (A61K, A23L, A61P) are complementary and do not necessitate separate searches that would impose a serious burden on examination.[Remarks, p. 8, par. 2]
Applicant’s 11/05/2025 Remarks, p. 7, par. 7, to p. 8, par. 2. In response: it is noted that since the claims drawn to the instant composition are not patentable over the references discussed below, restriction is still deemed proper. Further, it is noted that Groups I, II and III, as originally restricted 09/16/2014 Office action, are in separate areas of classification (i.e., the Group I composition in CPC A61K 36/82, the Group II method of making in CPC A23L 33/105, and the Group III method of using in CPC A61P 25/00), wherein the separate classification provides for the inventions of the respective groups as being distinct, and whereby art that would read on one group, would not read on another, and vice versa. Further, restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
(c) the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Accordingly, the September 17, 2025 Requirement for Restriction is made FINAL, and claims 1-4 and 8 are examined as follows.
Claim Objections
The following claims are objected to because of the following informalities:
Claim 8 is objected to under 37 C.F.R. § 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). However, claim 8 has been further treated on the merits for the purpose of expedited prosecution. Since claim 8 is directed to the formula of claim 1, while claim 2 appears directed to intended use, examine suggests amending claim 8 to read:
8. ([…]) A drug for s of the nervous system, wherein an active ingredient[[s]] of the drug isof claim 1wherein a dosage form of the drug is any one of a spray, a liquid preparation, an injectable preparation, a tablet, a capsule, a granule, a suspension mixture and a pill.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112, First Paragraph - 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.
Claim 8 is rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Scope of Enablement
Claim 8 is rejected under 35 U.S.C. § 112(a), because the specification, while being enabling for treating some kinds of “inflammation of the nervous system, the inflammation of the immune system and the degenerative disorder of the nervous system,” does not reasonably provide enablement for “preventing” said “inflammation” and “degenerative disorder.” 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. Specifically, the method of preventing “inflammation of the nervous system, the inflammation of the immune system and the degenerative disorder of the nervous system,” has not been sufficiently taught to enable the full scope of the claims. In this regard, the application disclosure and claims have been compared per the factors indicated in the decision In re Wands, 8 USPQ 2d 1400 (Fed. Cir., 1988) as to undue experimentation. The factors include:
(1) the nature of the invention;
(2) the scope or breadth of the claims;
(3) the state of the prior art;
(4) the predictability or unpredictability of the art;
(5) the relative skill of those skilled in the art;
(6) the presence or absence of working examples;
(7) the amount of direction or guidance presented and,
(8) the quantity of experimentation necessary.
The relevant factors are addressed below on the basis of comparison of the disclosure, the claims and the state of the prior art in the assessment of undue experimentation.
(1) Nature of the Invention & (2) Scope or Breadth of the Claims:
Instant claim 8 recites:
8. ([…]) A drug for prevention and/or treatment of the inflammation of the nervous system, the inflammation of the immune system and the degenerative disorder of the nervous system, active ingredients of the drug include the formula as described in claims 1 and 2; a dosage form of the drug is any one of a spray, a liquid preparation, an injectable preparation, a tablet, a capsule, a granule, a suspension mixture and a pill.
However, the instant specification as originally filed lacks adequate guidance, direction or discussion to apprise the skilled artisan of how to prevent “inflammation of the nervous system, the inflammation of the immune system and the degenerative disorder of the nervous system.” The claims are broad in that they claim a method for preventing “inflammation” and “degenerative disorder,” the breadth of which exacerbates the complexity of the invention. The term “preventing” is a potent and absolute term indicating that the method of prevention will necessarily prevent the onset of any “inflammation of the nervous system, the inflammation of the immune system and the degenerative disorder of the nervous system,” regardless of the cause, and in every instance by the administration of an effective amount of the “drug” including “the formula as described in claims 1 and 2.” Since the instant specification provides no limiting definition of the term “preventing,” the term has been interpreted expansively. The term “preventing” encompasses a wide range of situations, from preventing a disease from occurring to preventing it from progressing. Nor is the term limited by any time frame.
Applicant is claiming a drug for “preventing” of “inflammation of the nervous system, the inflammation of the immune system and the degenerative disorder of the nervous system” in claim 8. Prevention, as defined by Merriam-Webster Dictionary, is to keep from happening or existing, which implies taking advance measures against something possible or probable. Furthermore, the act of preventing embraces complete 100% inhibition. Thus, the burden of enablement in the assertion of this claim is much higher than would be the case of enabling simply the treatment of the condition. As for the instant application in relation to the prior art, neither the prior art nor the instant application enable for prevention of “inflammation” and “degenerative disorder.” Nowhere in the instant application has the efficacy of the “drug” including “the formula as described in claims 1 and 2” been enabled to prevent the occurrence of “inflammation” and “degenerative disorder.” Since absolute success in preventing most diseases/conditions is not reasonably possible, the specification, which lacks an objective showing that “inflammation” and “degenerative disorder” can actually be prevented, is viewed as lacking an adequate written description of the same.
The claim is thus extremely broad insofar as it suggests that following administration of the claimed compound, one will not experience “inflammation” and “degenerative disorder” from a “drug” including “the formula as described in claims 1 and 2”; that should one already have said “inflammation” and “degenerative disorder,” it will not worsen; and that it will not recur in any other cells of the body. For instance, the full scope of the claim encompasses the situation where administration of a “drug” including “the formula as described in claims 1 and 2” necessarily requires that any cell of the body on that individual will never experience “inflammation” and “degenerative disorder” from the time of the administration forward. While such prevention might theoretically be possible under strictly controlled laboratory conditions, as a practical matter it is nearly impossible to achieve in the “real world” in which patients live.
(3) State of the prior art
A “drug” including “the formula as described in claims 1 and 2” is known. See, for instance, WANG (CN 107812068 A, Publ. Mar. 20, 2018; as evidenced by English language translation of CN 107812068 A; on 06/20/2023 IDS; hereinafter, “Wang”), which discloses, at abstract, “a formula powder and solution based on tea extract; the formula powder includes tea extract and one or more inorganic salts,” wherein “[t]he tea extract also includes theanine and tea polysaccharide, or one of the two,” and “[t]he inorganic salt is sodium chloride.” However, Wang does not teach the use of the instant drug in preventing “inflammation” and “degenerative disorder” per the absolute meaning of “prevent,” as noted above. Thus, the state of the art with regard to using to prevent “inflammation” and “degenerative disorder” is essentially non-existent. Examples of “inflammation of the nervous system, the inflammation of the immune system and the degenerative disorder of the nervous system” have not been described in the art.
(4) Degree of Predictability or Unpredictability in the Art
The ability to prevent “inflammation of the nervous system, the inflammation of the immune system and the degenerative disorder of the nervous system” assumes that one is able to know where said toxicity will occur before it occurs. Accurate, reliable, and reproducible prediction of where said toxicity will occur on a mammal has not been demonstrated and is therefore highly unpredictable at this time.
(5) Relative Skill Possessed by Those in the Art
In view of the discussion of the state and predictability of the prior art, and the scope of the claims, which are drawn to a “drug” including “the formula as described in claims 1 and 2” for “inflammation of the nervous system, the inflammation of the immune system and the degenerative disorder of the nervous system,” the level of skill in the art is high and is at least that of a medical doctor or Ph.D. scientist with several years of experience in the field(s) of neurology.
(6) Presence or Absence of Working Examples
No working examples of preventing “inflammation of the nervous system, the inflammation of the immune system and the degenerative disorder of the nervous system” were provided since applicant’s specification describes the use of compounds of a “drug” including “the formula as described in claims 1 and 2” for treating “inflammation of the nervous system, the inflammation of the immune system and the degenerative disorder of the nervous system.” Therefore, the instant specification describes treatment of “inflammation” and “degenerative disorder,” but not “prevention” in the absolute meaning of the word “prevent,” but instead, treated.
(7) Amount of Guidance or Direction Provided
In considering the guidance provided in the specification, the use of a “drug” including “the formula as described in claims 1 and 2” for treating “inflammation of the nervous system, the inflammation of the immune system and the degenerative disorder of the nervous system.” is described in the instant published application, US 2024/0189382 A1, at par. [0042]-[0135], but not preventing “inflammation” and “degenerative disorder” in the absolute meaning of “prevent,” noted above. In this respect, no guidance is presented as to how one determines what cells are expected to experience “inflammation” and “degenerative disorder.” This is particularly important regarding the term, “prevention,” since it is not within the skill of the ordinary artisan to accurately predict which cells will have experience said “inflammation” and “degenerative disorder.” Thus, in the absence of such guidance in the specification, the ordinary artisan would not know how to identify cells that may experience said “inflammation” and “degenerative disorder.”
(8) Quantity of Experimentation Required to Make and Use the Invention
In view of the factors discussed above, the state of the art with regard to preventing “inflammation” and “degenerative disorder” in general is fairly complex and sufficiently unpredictable such that the skilled artisan would have been required to undertake undue experimentation to determine the exact conditions and manner and/or process of execution to arrive at those conditions amenable to actually preventing said “inflammation” and “degenerative disorder” in the absence of detailed guidance to this effect. Absent such direction or guidance as to how the skilled artisan would go about preventing said “inflammation” and “degenerative disorder,” one of ordinary skill in the art would have no alternative recourse but to undertake an exhaustive, and, thus, unduly burdensome search of methods to practice the claimed invention.
Claim Rejections – 35 U.S.C. § 112 - Indefiniteness
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.
Claims 1-4 and 8 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 pre-AIA , that applicant regards as the invention.
A. Claim 1 is drawn to:
1. ([…]) A formula for inhibiting aging and promoting regeneration and repair, wherein, the formula comprises tea and sodium chloride; the tea consists of any combination of one or more types of tea, such as wulong tea, green tea, white tea, yellow tea, dark tea, and black tea, etc.; amino acids and other small molecules in tea ingredients, in terms of types and proportions, meet the needs of various neurotransmitters within the human nervous system; types and proportions of small molecules, such as amino acids, in tea ingredients are in accordance with needs of various neurotransmitters within human nervous system; one of the formulas comprises Tieguanyin tea and sodium chloride; a preparation method of a solution of the formula is as follows: dissolved ingredients of Tieguanyin tea in water until ingredients of the tea reaching or close to the highest dissolution concentration, adding sodium chloride to bring the solution to a state in which sodium ions and chloride ions are saturated (sodium chloride in the solution reaches its maximum solubility).
wherein the use of “consists of” with “one or more types,” “such as” and “etc.” in the recitation, “consists of any combination of one or more types of tea, such as wulong tea, green tea, white tea, yellow tea, dark tea, and black tea, etc.,” is indefinite. The use of closed, “consists of” transitional phrasing renders the metes and bounds of the claim unclear a to whether or not the claims are open to other tea besides those recited because:
the use of “consists of” for a narrow range of “wulong tea, green tea, white tea, yellow tea, dark tea, and black tea” suggests the claim is closed to other teas, such as the later-recited, “Tieguanyin tea” (to the extent “Tieguanyin tea” is not encompassed by any of “wulong tea, green tea, white tea, yellow tea, dark tea, and black tea”);
whereas as the use of “one or more types,” “such as” and “etc.” suggests a broad range open to other tea.
See MPEP § 2111.03 regarding transitional phrases. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by “such as” and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). Also, the use of the phrase “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d) In this regard, examiner suggests amending claim 1 to read:
1. ([…]) A formula for inhibiting aging and promoting regeneration and repair, wherein[[,]] the formula comprises tea and sodium chloride; wherein the tea is slected from Tieguanyin tea, and combinations thereofwherein the tea contains amino acids and for absorption and transformation to
Subsequent claims 2-4 and 8 depend on claim 1 and are thus, indefinite as well.
B. Claim 1 is also indefinite in the recitation:
“one of the formulas comprises Tieguanyin tea and sodium chloride; a preparation method of a solution of the formula is as follows: dissolved ingredients of Tieguanyin tea in water until ingredients of the tea reaching or close to the highest dissolution concentration, adding sodium chloride to bring the solution to a state in which sodium ions and chloride ions are saturated (sodium chloride in the solution reaches its maximum solubility),”
because it is unclear whether or not this recitation is exemplary or limiting. In this regard, it is noted that the Board has held: “if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.” Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (expanded panel). To the extent applicant intends the latter, examiner suggests deleting this section from claim 1, and adding a further dependent claim in product-by-process form directed to “Tieguanyin tea” and “sodium chloride”:
9. (New) The formula according to claim 1, wherein the formula is obtained by a process comprising:
dissolving Tieguanyin tea in water until ingredients of the tea reaches, or is close to a highest dissolution concentration of the tea,
adding sodium chloride to bring the solution to a state in which sodium ions and chloride ions are saturated, wherein sodium chloride in the solution reaches maximum solubility.
C. Claim 2 is drawn to:
2. ([…]) The formula according to claim 1, wherein, the formula is applied to fixed positions of organs such as the eyes, nose, mouth, nipples, genitals, rectum, skin, lungs, etc., along fixed paths of the human nervous system for non-invasive drug administration, in order to reach the nervous system throughout the body and achieve long-distance drug delivery to the human nervous system; methods of drug administration also include microneedle administration and atomization administration; the fixed paths for non-invasive drug administration include: the drug administrated to the eyes is delivered to the heart through the occipital bone and the sacrum; the drug administrated to the nose is delivered to the ear through the trigeminal nerve; the drug administrated by nasal and oral atomization is delivered to the lungs and cervical nerves; the mouth and rectum are the two ends of the digestive system, the drug administrated through the mouth is delivered to the dental nerves, the neck and the stomach; the drug administrated through the rectal administration is delivered to the stomach and the neck along the digestive system; the drug administrated through the rectal administration is delivered to the to the sacral plexus and the nerves surrounding the anus; the drug administrated through the external genitalia is delivered to the sacral plexus, lumbar plexus, sciatic nerve, plantar nerves, superior gluteal nerve, inferior gluteal nerve, sexual nerves, urinary bladder, kidneys, and so on; the drug administrated through the nipple is delivered to the thoracic dorsal nerve, brachial plexus, cervical nerves, ulnar nerve, hand, facial nerve; the drug administrated to the skin is delivered to the neuroreceptors under the skin.
wherein the uses of “such as,” “etc.” and “so on” render the claim indefinite because it is unclear whether the limitations following the instance of “such as,” “etc.” and “so on” are part of the claimed invention. It is noted that descriptions of examples and preferences are properly set forth in the specification rather than in a claim. See MPEP § 2173.05(c). In this regard, examiner suggests amending claim 2 to read:
2. ([…]) The formula according to claim 1, wherein, the formula is noninvasively applied to fixed positions of organs in order to achieve long-distance drug delivery to the nervous system, wherein the fixed positions of organs are and lungswherein the fixed position are administered to by
C. Claim 3 is drawn to:
3. ([…]) The formula according to claim 1, wherein, a solution in which sodium chloride reaches a saturated concentration and a concentration of tea is close to saturation can be prepared according to the formula; a formula solution with high-concentration can be safely applied within sodium ion channels of human nervous system, while safely increasing concentration of sodium ions inside and outside neuronal cell membrane; concentrations of sodium ions, chloride ions, and small molecules such as amino acids inside and outside the neuronal cell membrane are simultaneously elevated by the formula, which is crucial for regeneration of a body; the formula solution is actively absorbed by human nervous system and is converted into multiple types of neurotransmitters; by a stronger electrical signal level, inflammation, cancer, bacterial and viral infections can be effectively inhibited, and transmission of inflammatory pain signals can be blocked; the concentration of sodium ions outside the neuronal cell membrane in the human body is approximately 150 mmol/L, and concentration of sodium ions outside the neuronal cell membrane of regenerative animals such as octopuses and squids is around 440 mmol/L; it is speculated that if the concentration of sodium ions outside the neuronal cell membrane in the human body exceeds 440 mmol/L, a regeneration process may be triggered; sodium ion channels are most abundant in the nervous system, and safe regulation of sodium ion channels is crucial for functions of the nervous system; a concentration of Tieguanyin and a concentration of sodium chloride in the formula solution have reached their saturation point, resulting in a sodium ion concentration of 4524 mmol/L; a concentration of sodium ions in the malignant tumor cell environment is 451 mmol/L, and a concentration of sodium ions in the inflammatory cell environment ranges from 200 to 300 mmol/L; 4524>451>440>300>200>150; the formula solution with a sodium ion concentration of 4524 mmol/L which can be safely and continuously used to human tissue and organs can be used to inhibit malignant tumors a sodium ion concentration in which is 451 mmol/L and pains caused by malignant tumors, and to suppress inflammation and edema a sodium ion concentration in which is 200-300 mmol/L and pains caused by the inflammation; in the specific implementation, the concentration of sodium ions outside the neuronal cell membrane in the human body can be increased from 150 to nearly 4524 mmol/L and then decreased back to 150 mmol/L; the solution is regularly and cyclically used every day to establish a repair and regeneration pattern that complies with the sodium ion spiral curve; the concentration of sodium ions in the solution starts from 150, reaches 4524, decreases to 150, and then reaches 4524 again, repeating in a regular cyclic pattern; when the concentration of sodium ions outside the neuronal cell membrane in the human body reaches or exceeds 440 mmol/L which is the concentration of sodium ions in the octopus cells, regenerative functions of cells is triggered; a cumulative regenerative frequency is maintained in a regular pattern every day, achieving an effect close to the regenerative capacity of an octopus.
wherein the recitation, “a concentration of Tieguanyin and a concentration of sodium chloride in the formula solution have reached their saturation point, resulting in a sodium ion concentration of 4524 mmol/L,” is indefinite for rendering the metes and bounds of the claim unclear as to whether or not being limiting of the previously recited, “formula” or “solution in which sodium chloride reaches a saturated concentration and a concentration of tea is close to saturation.” Further, the recitations:
“a formula solution with high-concentration can be safely applied within sodium ion channels of human nervous system, while safely increasing concentration of sodium ions inside and outside neuronal cell membrane; concentrations of sodium ions, chloride ions, and small molecules such as amino acids inside and outside the neuronal cell membrane are simultaneously elevated by the formula, which is crucial for regeneration of a body; the formula solution is actively absorbed by human nervous system and is converted into multiple types of neurotransmitters; by a stronger electrical signal level, inflammation, cancer, bacterial and viral infections can be effectively inhibited, and transmission of inflammatory pain signals can be blocked; the concentration of sodium ions outside the neuronal cell membrane in the human body is approximately 150 mmol/L, and concentration of sodium ions outside the neuronal cell membrane of regenerative animals such as octopuses and squids is around 440 mmol/L; it is speculated that if the concentration of sodium ions outside the neuronal cell membrane in the human body exceeds 440 mmol/L, a regeneration process may be triggered; […]; a concentration of sodium ions in the malignant tumor cell environment is 451 mmol/L, and a concentration of sodium ions in the inflammatory cell environment ranges from 200 to 300 mmol/L; 4524>451>440>300>200>150; the formula solution with a sodium ion concentration of 4524 mmol/L which can be safely and continuously used to human tissue and organs can be used to inhibit malignant tumors a sodium ion concentration in which is 451 mmol/L and pains caused by malignant tumors, and to suppress inflammation and edema a sodium ion concentration in which is 200-300 mmol/L and pains caused by the inflammation; in the specific implementation, the concentration of sodium ions outside the neuronal cell membrane in the human body can be increased from 150 to nearly 4524 mmol/L and then decreased back to 150 mmol/L; the solution is regularly and cyclically used every day to establish a repair and regeneration pattern that complies with the sodium ion spiral curve; the concentration of sodium ions in the solution starts from 150, reaches 4524, decreases to 150, and then reaches 4524 again, repeating in a regular cyclic pattern; when the concentration of sodium ions outside the neuronal cell membrane in the human body reaches or exceeds 440 mmol/L which is the concentration of sodium ions in the octopus cells, regenerative functions of cells is triggered; a cumulative regenerative frequency is maintained in a regular pattern every day, achieving an effect close to the regenerative capacity of an octopus”
appears to be a regimen of use, which, should be in either a separate, dependent claim for an intended use, or a separate claim drawn to a method of using, with the latter delineating clear active steps. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. See for example Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). To the extent applicant intends to recite a saturated composition dependent on claim 1, examiner suggests amending claim 3 to read:
3. ([…]) The formula according to claim 1, whereinthe sodium chloride reaches a saturated concentration and a concentration of the tea is close to saturation above 40 to 70 mg/ml
and adding a new dependent claim drawn to a more particular tea, namely Tieguanyin.
D. Claim 4 is drawn to:
4. ([…]) The formula according to claim 1, wherein, the drug is administered noninvasively along a fixed pathway in the nervous system; accumulating number of times of the regeneration in a regular manner to suppress aging; the usage time and dosage are as follows: 1-2 times per day; for the eyes, the usage time is approximately one minute each time, and the dosage is 0.1-1 milliliters each time; for the nose, the usage time is approximately two minutes each time, and the dosage is 0.1-1 milliliters each time; for the mouth, the usage time is about 2 minutes each time, and the dosage is 5-10 milliliters each time; for the lung atomization, the usage time is about 30 minutes each time, and the dosage is 5-20 milliliters each time; for the reproductive organs, the usage time is about 10-20 minutes each time, and the dosage is 5-10 milliliters each time; for the nipples, the usage time is about 10 minutes each time, and the dosage is 10 milliliters each time; for the rectum, the usage time is about one minute each time, and the dosage is 5-10 milliliters each time; for the skin, the usage time is about 5-10 minutes each time, and the dosage is 60 milliliters each time; other methods, such as injection, involve minimal injection volumes of approximately 0.1 milliliters each time; for diseases which are more serious, the time for the non-invasive drug administration can be extended to several hours per day, with the nervous system taking in the drug actively and accelerating the inhibition of inflammation.
wherein the recitation “the regeneration” is indefinite for insufficient antecedent basis for this limitation in the claim as no “regeneration” is recited in claim 1 from which claim 4 depends. See MPEP § 2173.05(e). Also, the use of “other methods” and “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In this regard, examiner suggests amending claim 4 to read:
4. ([…]) The formula according to claim 1, wherein, the drug is administered noninvasively along a fixed pathway in order to achieve long-distance drug delivery to the nervous system; wherein usage time and dosage are
wherein for the eyes, the usage time is approximately one minute each time, and the dosage is 0.1-1 milliliters each time;
wherein for the nose, the usage time is approximately two minutes each time, and the dosage is 0.1-1 milliliters each time;
wherein for the mouth, the usage time is about 2 minutes each time, and the dosage is 5-10 milliliters each time;
wherein for the lung atomization, the usage time is about 30 minutes each time, and the dosage is 5-20 milliliters each time;
wherein for the reproductive organs, the usage time is about 10-20 minutes each time, and the dosage is 5-10 milliliters each time;
wherein for the nipples, the usage time is about 10 minutes each time, and the dosage is 10 milliliters each time;
wherein for the rectum, the usage time is about one minute each time, and the dosage is 5-10 milliliters each time;
wherein for the skin, the usage time is about 5-10 minutes each time, and the dosage is 60 milliliters each time
Further clarification is required.
Claim Rejections – 35 U.S.C. § 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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 1-4 and 8 are rejected under 35 U.S.C. § 103 as being unpatentable over WANG (CN 107812068 A, Publ. Mar. 20, 2018; as evidenced by English language translation of CN 107812068 A; on 06/20/2023 IDS; hereinafter, “Wang”), in view of MAVROUDIS (US 2008/0254189 A1, Publ. Oct. 16, 2008; hereinafter, “Mavroudis”).
Page and paragraph numbers for Wang refer to English language translation of CN 107812068 A.
Wang is directed to:
Formula powder and solution based on a kind of tea extract
Abstract
The present invention proposes a formula powder and solution based on tea extract; the formula powder includes tea extract and one or more inorganic salts contained in the human body; the tea extract is tea polyphenol; wherein the ratio of polyphenols to inorganic salts is 0.05-1:1. The tea extract also includes theanine and tea polysaccharide, or one of the two. The inorganic salt is sodium chloride or magnesium chloride; the present invention uses the tea extract as raw material, which can inhibit the growth of pathogenic microorganisms, improve resistance, and promote the recovery of nasal cavity tissue in addition to being able to clean. The osmotic pressure and cell The osmotic pressure is comparable, so it is comfortable to use.
Wang, title & abstract. In this regard, Wang exemplifies claim embodiments directed to a formula powder based on tea extract and solution of the formula powder:
1. A kind of 1. formula powder based on tea extract, it is characterised in that: Including tea extract and one or more human bodies Contained inorganic salts; Described tea extract is Tea Polyphenols; Wherein the ratio of Tea Polyphenols and inorganic salts is 0.05-1:1.
2. the formula powder based on a kind of tea extract according to claim 1, it is characterised in that: Described tealeaves carries Thing is taken also to include one kind in theanine and tea polysaccharide, or two kinds.
3. the formula powder based on a kind of tea extract according to claim 1, it is characterised in that: Described inorganic salts For sodium chloride or magnesium chloride.
4. the formula powder based on a kind of tea extract according to claim 1 or 2, it is characterised in that: Tea Polyphenols, tea The mass ratio of propylhomoserin, tea polysaccharide and sodium chloride is (0.05-1): (0-1.75): (0-7.6): 1; Tea extract and sodium chloride Mass ratio.
5. A kind of 5. solution of the formula powder based on tea extract according to claim 1 or 2 or 3, it is characterised in that: By tea extract, the one or more of the inorganic salts contained by human body, water is dissolved in, the osmotic pressure for obtaining solution is 200- 400mmol/L。
6. the solution of the formula powder based on a kind of tea extract according to claim 5, it is characterised in that: Described Tea extract also includes one kind in theanine and tea polysaccharide, or two kinds.
7. A kind of 7. solution of the formula powder based on tea extract according to claim 5 or 6, it is characterised in that: Osmotic pressure to solution is 280- 320mmol/L.
8. A kind of 8. solution of the formula powder based on tea extract according to claim 5 or 6, it is characterised in that: Tension force to solution is equal with the tension force of schneiderian membrane cell isotonic solution.
Wang, claims 1-8.
Regarding independent claim 1 and the requirements:
1. ([…]) A formula for inhibiting aging and promoting regeneration and repair, wherein, the formula comprises tea and sodium chloride; the tea consists of any combination of one or more types of tea, such as wulong tea, green tea, white tea, yellow tea, dark tea, and black tea, etc.; amino acids and other small molecules in tea ingredients, in terms of types and proportions, meet the needs of various neurotransmitters within the human nervous system; types and proportions of small molecules, such as amino acids, in tea ingredients are in accordance with needs of various neurotransmitters within human nervous system; one of the formulas comprises Tieguanyin tea and sodium chloride; a preparation method of a solution of the formula is as follows: dissolved ingredients of Tieguanyin tea in water until ingredients of the tea reaching or close to the highest dissolution concentration, adding sodium chloride to bring the solution to a state in which sodium ions and chloride ions are saturated (sodium chloride in the solution reaches its maximum solubility).
Wang clearly teaches a formula powder based on tea extract and solution of the formula powder (Wang, claims 1-8), WHEREBY it is noted “the solution of the formula powder based on a kind of tea extract according to claim 5” (Wang, claims 6-8) contains:
“Tea extract [that] also includes one kind in theanine and tea polysaccharide” (Wang, claim 6) reads on “tea” of claim 1; and
“inorganic salts” such as “sodium chloride” (Wang, claims 3-4) reads on “sodium chloride” of claim 1.
However, to the extent Wang DOES NOT EXPRESSLY TEACH a particular tea, such as “black tea” per the requirement of claim 1, the selection thereof is well within the purview of the ordinarily skilled artisan.
Mavroudis, for instance, is directed to:
PROCESS FOR MAKING TEA EXTRACTS
ABSTRACT
The invention concerns a process for provising a tea extract which is rich in naturally occuring theanine. The process involves a cold water extraction followed by a specific nanofiltration step. Also claimed are the cold water extracts.
Mavroudis, title & abstract. In this regard, Mavroudis discusses background and prior art of tea that is “generally prepared as green leaf tea or black leaf tea”:
BACKGROUND AND PRIOR ART
[0002] Tea is generally prepared as green leaf tea or black leaf tea. The method of preparing such teas is well known to those skilled in the art. Generally, to prepare black leaf tea, fresh green leaves of the plant Camellia sinensis are withered (subjected to mild drying), comminuted, fermented (in which enzymes in the leaf tea oxidise various substrates to produce brown-coloured products) and then fired (to dry the tea leaves). Green leaf tea is not exposed to the fermentation process. Partial fermentation may be used to produce intermediate-type teas known as “oolong” tea.
Mavroudis, par. [0002]. Further in this regard, Mavroudis teaches as extraction from black tea
[0016] Tea Starting Material
[0017] The starting material of the present invention is tea plant material. Material from Camellia sinensis, Camellia assamica, or Aspalathus linearis. Preferably the starting material is black tea, in which the leaves and/or stem are subjected to a so-called “fermentation” step wherein they are oxidised by certain endogenous enzymes that are released during the early stages of “black tea” manufacture. This oxidation may even be supplemented by the action of exogenous enzymes such as oxidases, laccases and peroxidases. The fermentation process is believed to polymerise the polyphenols which may cause difficulties with the sensitive filters used in the present invention.
[0018] Cold Water Extraction
[0019] The cold water extraction is carried out with water at a temperature of from 1 to 50° C. for a time period of from 1 to 120 minutes. Preferably, the temperature and duration are such that the product of the temperature in degrees Celsius and the duration of the extraction in minutes (Cmins) is from 30 to 1000, preferably from 100 to 500.
Mavroudis, par. [0016]-[0019].
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to prepare Wang’s formula powder based on tea extract (Wang, claims 1-8), wherein the tea extract is from black tea per Mavroudis (Mavroudis, par. [0016]-[0019]). One would have been motivated to do so with a reasonable expectation of success in order to obtain the advantage of a suitable source of a “tea extract which is rich in naturally occuring theanine.” Mavroudis, abstract.
Further regarding claim 1, it is noted that the requirement for:
“amino acids and other small molecules in tea ingredients, in terms of types and proportions, meet the needs of various neurotransmitters within the human nervous system; types and proportions of small molecules, such as amino acids, in tea ingredients are in accordance with needs of various neurotransmitters within human nervous system,”
as well as the requirements of claims 2-4 for:
2. ([…]) The formula according to claim 1, wherein, the formula is applied to fixed positions of organs such as the eyes, nose, mouth, nipples, genitals, rectum, skin, lungs, etc., along fixed paths of the human nervous system for non-invasive drug administration, in order to reach the nervous system throughout the body and achieve long-distance drug delivery to the human nervous system; methods of drug administration also include microneedle administration and atomization administration; the fixed paths for non-invasive drug administration include: the drug administrated to the eyes is delivered to the heart through the occipital bone and the sacrum; the drug administrated to the nose is delivered to the ear through the trigeminal nerve; the drug administrated by nasal and oral atomization is delivered to the lungs and cervical nerves; the mouth and rectum are the two ends of the digestive system, the drug administrated through the mouth is delivered to the dental nerves, the neck and the stomach; the drug administrated through the rectal administration is delivered to the stomach and the neck along the digestive system; the drug administrated through the rectal administration is delivered to the to the sacral plexus and the nerves surrounding the anus; the drug administrated through the external genitalia is delivered to the sacral plexus, lumbar plexus, sciatic nerve, plantar nerves, superior gluteal nerve, inferior gluteal nerve, sexual nerves, urinary bladder, kidneys, and so on; the drug administrated through the nipple is delivered to the thoracic dorsal nerve, brachial plexus, cervical nerves, ulnar nerve, hand, facial nerve; the drug administrated to the skin is delivered to the neuroreceptors under the skin.
[…]
3. ([…]) […]; a formula solution with high-concentration can be safely applied within sodium ion channels of human nervous system, while safely increasing concentration of sodium ions inside and outside neuronal cell membrane; concentrations of sodium ions, chloride ions, and small molecules such as amino acids inside and outside the neuronal cell membrane are simultaneously elevated by the formula, which is crucial for regeneration of a body; the formula solution is actively absorbed by human nervous system and is converted into multiple types of neurotransmitters; by a stronger electrical signal level, inflammation, cancer, bacterial and viral infections can be effectively inhibited, and transmission of inflammatory pain signals can be blocked; the concentration of sodium ions outside the neuronal cell membrane in the human body is approximately 150 mmol/L, and concentration of sodium ions outside the neuronal cell membrane of regenerative animals such as octopuses and squids is around 440 mmol/L; it is speculated that if the concentration of sodium ions outside the neuronal cell membrane in the human body exceeds 440 mmol/L, a regeneration process may be triggered; sodium ion channels are most abundant in the nervous system, and safe regulation of sodium ion channels is crucial for functions of the nervous system; […]; a concentration of sodium ions in the malignant tumor cell environment is 451 mmol/L, and a concentration of sodium ions in the inflammatory cell environment ranges from 200 to 300 mmol/L; 4524>451>440>300>200>150; the formula solution with a sodium ion concentration of 4524 mmol/L which can be safely and continuously used to human tissue and organs can be used to inhibit malignant tumors a sodium ion concentration in which is 451 mmol/L and pains caused by malignant tumors, and to suppress inflammation and edema a sodium ion concentration in which is 200-300 mmol/L and pains caused by the inflammation; in the specific implementation, the concentration of sodium ions outside the neuronal cell membrane in the human body can be increased from 150 to nearly 4524 mmol/L and then decreased back to 150 mmol/L; the solution is regularly and cyclically used every day to establish a repair and regeneration pattern that complies with the sodium ion spiral curve; the concentration of sodium ions in the solution starts from 150, reaches 4524, decreases to 150, and then reaches 4524 again, repeating in a regular cyclic pattern; when the concentration of sodium ions outside the neuronal cell membrane in the human body reaches or exceeds 440 mmol/L which is the concentration of sodium ions in the octopus cells, regenerative functions of cells is triggered; a cumulative regenerative frequency is maintained in a regular pattern every day, achieving an effect close to the regenerative capacity of an octopus.
4. ([…]) The formula according to claim 1, wherein, the drug is administered noninvasively along a fixed pathway in the nervous system; accumulating number of times of the regeneration in a regular manner to suppress aging; the usage time and dosage are as follows: 1-2 times per day; for the eyes, the usage time is approximately one minute each time, and the dosage is 0.1-1 milliliters each time; for the nose, the usage time is approximately two minutes each time, and the dosage is 0.1-1 milliliters each time; for the mouth, the usage time is about 2 minutes each time, and the dosage is 5-10 milliliters each time; for the lung atomization, the usage time is about 30 minutes each time, and the dosage is 5-20 milliliters each time; for the reproductive organs, the usage time is about 10-20 minutes each time, and the dosage is 5-10 milliliters each time; for the nipples, the usage time is about 10 minutes each time, and the dosage is 10 milliliters each time; for the rectum, the usage time is about one minute each time, and the dosage is 5-10 milliliters each time; for the skin, the usage time is about 5-10 minutes each time, and the dosage is 60 milliliters each time; other methods, such as injection, involve minimal injection volumes of approximately 0.1 milliliters each time; for diseases which are more serious, the time for the non-invasive drug administration can be extended to several hours per day, with the nervous system taking in the drug actively and accelerating the inhibition of inflammation.
are interpreted as a recitation of intended use. In this regard, it is noted that recitations of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it reads on the claim. See MPEP § 2103 (I)(C)). Since Wang and Mavroudis teach the structure of the instant formula, then it reasonably follows that Wang per Mavroudis’ formula would be capable of performing the intended use recited in claim 1.
Further regarding claim 1, it is noted that the requirement for “one of the formulas comprises Tieguanyin tea and sodium chloride; a preparation method of a solution of the formula is as follows: dissolved ingredients of Tieguanyin tea in water until ingredients of the tea reaching or close to the highest dissolution concentration, adding sodium chloride to bring the solution to a state in which sodium ions and chloride ions are saturated (sodium chloride in the solution reaches its maximum solubility)” is interpreted as an exemplary embodiment that is not further limiting since it is unclear as to whether or not this limitation is required.
Thus, the prior art renders claims 1-2 and 4 obvious.
Regarding claim 3 and the requirements:
3. ([…]) The formula according to claim 1, wherein, a solution in which sodium chloride reaches a saturated concentration and a concentration of tea is close to saturation can be prepared according to the formula; a formula solution with high-concentration can be safely applied within sodium ion channels of human nervous system, while safely increasing concentration of sodium ions inside and outside neuronal cell membrane; concentrations of sodium ions, chloride ions, and small molecules such as amino acids inside and outside the neuronal cell membrane are simultaneously elevated by the formula, which is crucial for regeneration of a body; the formula solution is actively absorbed by human nervous system and is converted into multiple types of neurotransmitters; by a stronger electrical signal level, inflammation, cancer, bacterial and viral infections can be effectively inhibited, and transmission of inflammatory pain signals can be blocked; the concentration of sodium ions outside the neuronal cell membrane in the human body is approximately 150 mmol/L, and concentration of sodium ions outside the neuronal cell membrane of regenerative animals such as octopuses and squids is around 440 mmol/L; it is speculated that if the concentration of sodium ions outside the neuronal cell membrane in the human body exceeds 440 mmol/L, a regeneration process may be triggered; sodium ion channels are most abundant in the nervous system, and safe regulation of sodium ion channels is crucial for functions of the nervous system; a concentration of Tieguanyin and a concentration of sodium chloride in the formula solution have reached their saturation point, resulting in a sodium ion concentration of 4524 mmol/L; a concentration of sodium ions in the malignant tumor cell environment is 451 mmol/L, and a concentration of sodium ions in the inflammatory cell environment ranges from 200 to 300 mmol/L; 4524>451>440>300>200>150; the formula solution with a sodium ion concentration of 4524 mmol/L which can be safely and continuously used to human tissue and organs can be used to inhibit malignant tumors a sodium ion concentration in which is 451 mmol/L and pains caused by malignant tumors, and to suppress inflammation and edema a sodium ion concentration in which is 200-300 mmol/L and pains caused by the inflammation; in the specific implementation, the concentration of sodium ions outside the neuronal cell membrane in the human body can be increased from 150 to nearly 4524 mmol/L and then decreased back to 150 mmol/L; the solution is regularly and cyclically used every day to establish a repair and regeneration pattern that complies with the sodium ion spiral curve; the concentration of sodium ions in the solution starts from 150, reaches 4524, decreases to 150, and then reaches 4524 again, repeating in a regular cyclic pattern; when the concentration of sodium ions outside the neuronal cell membrane in the human body reaches or exceeds 440 mmol/L which is the concentration of sodium ions in the octopus cells, regenerative functions of cells is triggered; a cumulative regenerative frequency is maintained in a regular pattern every day, achieving an effect close to the regenerative capacity of an octopus.
Wang teaches “tea extract, the one or more of the inorganic salts contained by human body, water is dissolved in, the osmotic pressure for obtaining solution is 200- 400mmol/L” (Wang, claim 5) for applications, wherein “the formula solution was added to the inflammatory nasal mucosa culture medium, and the nasal mucosa cells had no obvious toxic reaction; compared with normal saline, this formula solution can reduce the inflammatory reaction of the nasal mucosa” (Wang, p. 2, par. 11). In this regard, it is noted that dosage/amount of active ingredient is a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). Therefore, an ordinary skilled artisan would also be motivated to manipulate and optimize the dosage depending on a patient’s weight, age, tolerance, sex, and condition being treated, for instance, optimizing Wang teaches formula powder and solution thereof (Wang, claims 1-8) to saturation levels in optimizing osmotic pressure for inflammatory action, thereby meeting the requirements of claim 3 for “a solution in which sodium chloride reaches a saturated concentration and a concentration of tea is close to saturation can be prepared according to the formula.” Further regarding claim 1, it is noted that the requirement for a concentration of Tieguanyin and a concentration of sodium chloride in the formula solution have reached their saturation point, resulting in a sodium ion concentration of 4524 mmol/L” is interpreted as an exemplary embodiment that is not further limiting since it is unclear as to whether or not this limitation is required.
Thus, the prior art renders claim 3 obvious.
Regarding claim 8 and the requirements:
8. ([…]) A drug for prevention and/or treatment of the inflammation of the nervous system, the inflammation of the immune system and the degenerative disorder of the nervous system, active ingredients of the drug include the formula as described in claims 1 and 2; a dosage form of the drug is any one of a spray, a liquid preparation, an injectable preparation, a tablet, a capsule, a granule, a suspension mixture and a pill.
Wang teaches a formula powder based on tea extract and solution of the formula powder (Wang, claims 1-8), which at least meet the requirement of claim 8 for a “liquid preparation.”
Thus, the prior art renders claim 8 obvious.
Conclusion
Claims 1-4 and 8 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. 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.
/DOMINIC LAZARO/Primary Examiner, Art Unit 1611