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/CN2023/090966, filed 26 April 2023; and claims benefit of foreign priority document CHINA 202210493141.6, filed 07 May 2022. This foreign priority document is not in English and the priority claim is not perfected.
Claims 1-7 and 9-21 are pending in the current application and are examined on the merits herein.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. MPEP 606 provides a listing of words that are not considered as part of the title of an invention, should not be included at the beginning of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues. This listing includes the words “Improved”, “New”, and “Novel”.
In this case the title includes the word “New”, and will be deleted when the Office enters the title.
Claim Objections
Claims 13-15 are objected to because of the following informalities: claims 13-15 do not appear to end in a period. 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 6-7, 13-15, and 20-21 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 a method for preparing the crystalline form A of LNTII as claimed wherein the organic solvent is acetone, does not reasonably provide enablement for the full scope of organic solvents encompassed within the method. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or 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 preparing the crystalline form A of LNTII comprising mixing a solution containing LNTII with an organic solvent to obtain crystalline form A of LNTII.
The state of the prior art: Kovacs et al. (WO 2023/175130 A1, filed 17 March 2023, claiming priority to EP 22162658.3 filed 17 March 2022, cited in PTO-892) discloses a crystalline human milk oligosaccharide (HMO), notably the trisaccharide lacto-N-triose II (LNT2, 2-acetamido-2-deoxy-β-D-glucopyranosyl-(1-3)-β-D-galactopyranosyl(1-4)-D-glucose, GlcNAcβ1-3Galβ1-4Glc) in crystalline form and a method of obtaining it (page 1, line 5). Kovacs et al. discloses when LNT2 was crystallized from aqueous methanol it produces form 1, and when LNT2 was crystallized from aqueous acetone, a different polymorph was obtained as evidenced by its PXRD, its melting (decomposition point) is lower than that of form 1 (page 3, line 10-20; example 1 and 2 at page 13).
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: Kovacs et al. teaches crystallization of LNT2 from different solvents results in different crystalline polymorphs. Therefore the claimed invention is unpredictable.
The Breadth of the claims: The scope of the claims is infinite. Any possible chemical structure could potentially be used as the organic solvent.
The amount of direction or guidance presented: and The presence or absence of working examples: The only working examples provided are for preparing the crystalline form A of LNTII using the organic solvent acetone, from Example 1 at page 8 to Example 7 at page 10.
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 crystallization of compounds such as LNTII in different crystalline polymorphs. See MPEP 2164.
The quantity of experimentation necessary: In order to practice the invention using acetone as the organic solvent, one skilled in the art would undertake a novel and extensive research program into the preparation of crystalline form A of LNTII in different solvents. Because this research would have to be exhaustive, and because it would involve such a wide and unpredictable scope of reaction conditions, it would constitute an undue and unpredictable experimental burden.
Genentech, 108 F.3d 1361 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 all possible methods for preparing the crystalline form A of LNTII comprising mixing a solution containing LNTII with an organic solvent.
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.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites “A method comprising applying the crystalline form A of LNTII according to claim 1 as an intermediate or final product.” In this case it is unclear what the step of “applying” encompasses, how the LNTII is applied, and what the structure of the intermediate or final product is which results from applying the LNTII. See also MPEP 2173.05(q) providing “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” In this case the step of “applying” is analogous to a step of “using” the LNTII and is indefinite for reciting a use without any active, positive steps delimiting how this use is actually practiced.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 and 9-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kovacs et al. (WO 2023/175130 A1, filed 17 March 2023, claiming priority to EP 22162658.3 filed 17 March 2022, cited in PTO-892).
As the filing date of the priority document EP 22162658.3 is relied upon, citations to Kovacs et al. herein will be found in EP 22162658.3.
Kovacs et al. discloses a crystalline human milk oligosaccharide (HMO), notably the trisaccharide lacto-N-triose II (LNT2, 2-acetamido-2-deoxy-β-D-glucopyranosyl-(1-3)-β-D-galactopyranosyl(1-4)-D-glucose, GlcNAcβ1-3Galβ1-4Glc) in crystalline form and a method of obtaining it (page 1, line 5). In an aspect of the invention the crystalline form is referred to as form 2 (page 2, line 15). This form 2 includes listed powder X-ray diffraction reflections, based on a measurement using CuKα radiation, or those depicted in figure 3 (page 3, line 25 to page 4, line 5; figure 3). The PXRD pattern at figure 3 includes the claimed peaks having 2θ values of 4.80, 7.24, 8.32, 9.62, 9.89, 11.65, 12.72, 14.42, 16.67, 17.35, 18.67, 19.28, 19.90, 20.72, 21.05, 21.59, 22.14, 23.17, 23.71, 24.15, 25.20, 26.93, 28.68, 29.12, 29.49, 30.34, 31.08, 31.88, and 34.10, within the range of ± 0.2°, meeting limitations of claims 1-4. Kovacs et al. discloses the LNT2 form 2 prepared by adding 520 mL of acetone to 100 g of 50 m/m% LNT2 solution in water (page 13, line 15-25), meeting limitations of claims 6-7 and 13-19. The LNT2 form 2 has a melting point of 196-198 °C (page 13, line 20), meeting limitations of claims 5 and 10-12. The crystalline LNT2 can be formulated as a pharmaceutical composition which can be administered (page 9, line 1-15), interpreted as a method comprising applying the crystalline LNT2 either as an intermediate to prepare the formulation or administered as a final product, meeting limitations of claim 9.
Regarding claims 5 and 10-12, Kovacs et al. discloses the overlapping range with “sufficient specificity to constitute an anticipation under the statute” because in measuring the melting point the observer would specifically note each temperature within the recorded range. See MPEP 2131.03 at II.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kovacs et al. (WO 2023/175130 A1, filed 17 March 2023, claiming priority to EP 22162658.3 filed 17 March 2022, cited in PTO-892).
Kovacs et al. discloses as above addressing claims 1-7 and 9-19.
Kovacs et al. does not specifically teach
Kovacs et al. further teaches the general process for process for obtaining the crystalline LNT2 form 2 by crystallizing it from a mixture of water and acetone (page 9, line 25 to page 10, line 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Kovacs et al. through routine experimentation in order to determine the optimal concentration of water and acetone. One of ordinary skill in the art would have been motivated to modify the teachings of Kovacs et al. with a reasonable expectation of success because Kovacs et al. teaches the general process for obtaining the crystalline LNT2 form 2 by crystallizing it from a mixture of water and acetone and teaches the embodiment comprising providing a 45-55 m/m% solution of LNT2 in water, and adding 9-11 ml of acetone per 1 g of LNT2 in the aqueous solution to provide a suspension, suggesting it would have been obvious to optimize the particular amounts of water and acetone through routine experimentation. See also MPEP 2144.05 at II.A. providing “ “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”
Conclusion
No claim is found to be allowable.
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.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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