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 .
This application is the national stage entry of PCT/CN2022/078159, filed 28 Feb 2022; and claims benefit of foreign priority document CHINA 202111324427.3, filed 11 Oct 2021. This foreign priority document is not in English.
Claims 16-39 are pending in the current application and are examined on the merits herein.
Specification
The abstract of the disclosure is objected to because the abstract at line 4 recites “gulcohexaose”. This appears to be a typographical error for “glucohexaose”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
The specification throughout recites the term “gulcohexaose”. This appears to be a typographical error for “glucohexaose”. For example, at pages 6, paragraph 44; page 7, paragraph 45; and in the examples at pages 10, paragraph 62 through page 16, paragraph 83.
The specification at page 2, paragraph 9 recites “ performing enzyme degradation on glucomannan with cellulose ether to form the glucohexaose” (emphasis added). This appears to be a typographical error for “cellulase” based on the description at paragraph 45 and the working examples.
Appropriate correction is required.
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 34-39 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 alopecia comprising administering to a subject in need thereof a therapeutically effective amount of the glucohexaose, does not reasonably provide enablement for treating alopecia. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: A method for treating and preventing alopecia, wherein the method comprises a step of administering to a subject in need thereof a therapeutically effective amount of the glucohexaose.
The state of the prior art: The Cleveland Clinic (entry for Hair Loss, Cleveland Clinic website, last updated on 26 Aug 2021, 11 pages, cited in PTO-892) teaches the state of the art before the effective filing date of the invention regarding hair loss. The Cleveland Clinic teaches hair loss has many possible causes, and that you can’t prevent all types of hair loss, but you can take steps to help keep your hair healthy and minimize loss (page 3/11 and 7/11).
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: The Cleveland Clinic teaching the state of the art suggests that hair loss has many possible causes, and that you can’t prevent all types of hair loss, suggesting it would have been unpredictable to prevent the full scope of possible patients because the particular type of hair loss may or may not be preventable. Therefore the claimed invention is unpredictable.
The Breadth of the claims: The scope of the claims specifically includes prevention of alopecia.
The amount of direction or guidance presented and The presence or absence of working examples: The specification provides working examples of in vitro testing at pages 12-13 and animal model promoting fair follicle regeneration, or an animal model for the treatment of existing androgenetic alopecia.
Note that lack of working examples is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art such as the full scope of preventing alopecia. See MPEP 2164.
The quantity of experimentation necessary: In order to practice the invention with the full range of all possible treatment methods beyond those known in the art, (such as treatment of hair loss) one skilled in the art would undertake a novel and extensive research program to show that the administration of the compound fully prevented alopecia. Because this research would have to be exhaustive, and because it would involve such a wide and unpredictable scope of patients experiencing different possible causes of hair loss, it would constitute an undue and unpredictable experimental burden.
Genentech, 108 F.3d at 1366, states that, “a patent is not a hunting license. It is not a reward for search, but 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.”
Therefore, in view of the Wands factors, as discussed above, particularly the breadth of the claims, Applicants fail to provide information sufficient to practice the claimed invention for prevention of alopecia.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites “A glucohexaose, wherein the glucohexaose has a molecular structure of: Man-Man-Man-Man-Glc-Glc.” Claim 17 recites “The glucohexaose according to claim 16, wherein the glucohexaose contains an acetyl group of natural origin.” Claim 19 recites “The glucohexaose according to claim 18, wherein the glucohexaose has a linear structure.”
Regarding claims 16 and 17, the specification at paragraph 39 provides the following definition: “As used herein, in the molecular structure of the glucohexaose, the term “Man” refers to: a mannose unit.” The specification at paragraph 40 provides the following definition: “As used herein, in the molecular structure of the glucohexaose, the term “Glc” refers to: a glucose unit.” The ordinary usage in the art for the term “Man” or “mannose” is the compound having the systematic IUPAC name (3S,4S,5S,6R)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol. The ordinary usage in the art for the term “Glc” or “glucose” is the compound having the systematic IUPAC name (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanal (in linear form) or (3R,4S,5S,6R)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol (in cyclic form). For example, Watkins (Harris et al., eds., Advances in Human Genetics, 1980, Plenum Press, pages 1-21, cited in PTO-892) at pages 10-11 shows that the ordinary usage in the art distinguishes between a glucose (Glc), a glucosamine (GlcN), and an N-acetylated glucosamine (GlcNAc). In this case claim 17 appears to suggest that “Man” can be used to mean both Man and ManAc, or that “Glc” can be used to mean both Glc and GlcAc, as these terms would have been understood according to the ordinary usage in the art. Further, this raises additional uncertainty as to what other modifications are encompassed within the scope of the glucohexaose of claim 16. This may be clarified by specifying in independent claim 16 that the glucohexaose optionally contains an acetyl group of natural origin, such as supported by the specification at paragraph 5.
Regarding claims 16 and 19, the ordinary usage in the art for representing a polymeric structure such as the claimed glucohexaose having a molecular structure of Man-Man-Man-Man-Glc-Glc is to represent the bonds connecting the monomers as the dash “-”, indicating that the second Man is bonded to the first and the third Man, the third Man is bonded to second and the fourth Man, and so forth, describing a linear structure. The recitation in claim 19 renders claim 16 indefinite because it is unclear if claim 19 is the same scope as claim 16 which already describes a linear structure, or if the written molecular structure does not define chemical connectivity according to the ordinary usage in the chemical arts. For example, it is unclear if the order of the monosaccharides is required, or if claim 16 encompasses a hexaose of “Man-Man-Glc-Man-Man-Glc”. Additionally, Watkins (Harris et al., eds., Advances in Human Genetics, 1980, Plenum Press, pages 1-21, cited in PTO-892) at pages 19-21 shows that the ordinary usage in the art for representing linear versus branched oligosaccharide structures.
All of claims 17-39 depend from claim 16 and incorporate the language therein, and are indefinite for the same reasons detailed above.
Claim 21 recites “performing enzyme degradation on glucomannan with cellulose ether to form the glucohexaose.” (emphasis added) The term “cellulose ether” renders this claim indefinite because it is unclear if this is a typographical error for “cellulase” based on the description at paragraph 45 and the working examples, or what type of enzyme degradation is required by the claim and how cellulose ether is involved in the enzymatic reaction. Claims 22-27, 31-33, and 37-39 depend from claim 21 and incorporate all limitations therein, including the cited language.
Allowable Subject Matter
Claims 16-33 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The closest prior art is deemed to be Katsuraya et al. (Carbohydrate Polymers, 2003, 53, p183-189, cited in PTO-892).
Katsuraya et al. teaches the constitution of konjac glucomannan was determined by methylation analysis and 13C NMR spectroscopy. From the splitting of main chain signals the sequences of glucosyl and mannosyl units in konjac glucomannan are estimated and a model structure for the glucomannan is proposed (page 183, abstract). The basic structure of the model is composed of eight blocks, each of which containing one glucosyl block and one mannosyl block. Of eight glucosyl blocks, three are glucosyl units and five are cellobiosyl units. The length of mannosyl blocks changes from monomeric to presumably pentameric. For example, G–M–G–M2–G–M3–G2–M–G2–M2–G2–M3–G2–M4–G2–M5– (paragraph spanning pages 188-189). Katsuraya et al. teaches in the field of art previous work has been done to fractionate and identify oligosaccharides obtained by mild acid hydrolysis or enzymatic hydrolysis of glucomannan (page 138).
Katsuraya et al. does not specifically disclose the glucohexaose having the molecular structure of Man-Man-Man-Man-Glc-Glc (claim 16).
It would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teaching of Katsuraya et al. in order to select a specific glucohexaose. While Katsuraya et al. predicts in the proposed model structure for konjac glucomannan the presence of a block unit comprising a four mannose block and a two glucose block, Katsuraya et al. does not provide motivation or guidance to obtain this specific glucohexaose unit from within the konjac glucomannan structure.
Conclusion
No claim is currently in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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, Scarlett Goon can be reached at (571)270-5241. 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.
/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
Prosecution Insights