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 .
DETAILED ACTION
Responsive to claim set of 7MAR2023
Claims pending 1-14,16-17
Claims currently under consideration 1-14,16-17
Priority
This application has an actual filing date of 03/07/2023 and is a
371 of PCT/EP2021/074724 filed 09/08/2021.
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to European patent document EP 20195132.4, filed 09/08/2020. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Rejections - 35 USC § 112
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 1-14,16-17 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 the applicant regards as the invention.
Claim 10 recites the limitation " the first series” in line 6, twice in lines 7-8 and line 9. There is insufficient antecedent basis for these limitation in the claim, rendering the metes and bounds uncertain. Claim 11 and the second and third wherein clauses of claim 1 are each drawn to an ambiguous Markush group because as interpreted in MPEP 2173.05(h) the courts have held a Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196, whereas selected from the group "comprising" renders the claim unclear as to what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022).
Claims 1,10 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections or alternatively, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted structural cooperative relationships or omitted steps are as follows.
The second wherein clause of claim 1 is grammatically incongruent, being drawn to “wherein the organic solvent is selected from ... protic or aprotic, of low reactivity, that can serve to solve small molecules...” In particular, it is not clear if the quoted organic solvent has a property of being protic or aprotic, has what of low reactivity nor has what that can solvate small molecules”
Claim 1 recites the term n, however no range is indicated. Claim 11 is drawn to various salts with a semicolon separating anion and cation, which is not defined in the specification and has no art-recognized meaning. Claim 16 recites the term y and each of claims 10 and 16 both recite the term m, however no range is indicated. Consequently, the metes and bounds claim 1 is uncertain and 10 is further uncertain.
Each of claims 2-9, each repeatedly recite phrase "more preferably” and “most preferably,” phrases that both render the claims indefinite because it is unclear whether the limitations following constitute the metes and bounds of the claim or not and thereby part of the claimed invention. See MPEP § 2173.05(d).
Indeed, according to MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
In so far as the metes and bounds of the offending claim(s) may not be interpreted properly for the reasons above, all dependent claims therefrom claim 1 is rejected as being indefinite as well.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4,6-14,17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the Molecular Dimensions CryoProX™ & CryoSol™ brochure (public availability date 31DEC2025 per cite no. 3 on 7MAR2023 IDS).
Molecular Dimensions discloses throughout the document, especially the second and third pages and CryoSol™ section, a method including steps of: 1) screening soaking solutions by mixing organic solvent (os); compatible solute (cs); mother liquor (crystallization solution, a.k.a. crs) and/or water 2) transferring at least one crystal of a biological macromolecular crystal into the solution prepared in step 1); 3) controlling the crystal such as from evaporation; 4) selecting the soaking solution which is suitable for soaking the crystal by screening for ligand solubility, such that: the cs is, for example, a polyol such as PEG-400, ethylene glycol, glycerol or 2-methyl-2,4-pentanediol (MPD); and the os is, for instance, DMSO, an aprotic solvent of low reactivity, and salts such as sodium formate, optionally including small molecule fragments such as low affinity inhibitors or drugs that inherently diffuse into the biological macromolecular crystal. The foregoing appears to read on: claims 1,2,3,4,6,7,8,9,10,11,12,13,14,17 when n=0=m. See also indefiniteness rejection above.
Claim Rejections - 35 USC § 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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Collins et al (2017 Acta Cryst D73, pp 246-55 including supporting information) in view of MPEP 2114 & 2115.
Like claim 16, for instance when n=1=m; x=2; y=2, Collins et al disclose throughout the document, particularly the abstract, section 2.4 and figure S1, a crystal soaking plate that constitutes an array that has separate compartments arranged in at least two columns and at least two rows. Collins et al do not expressly teach the os,cs,crs and water recited in claim 16 nor the method of using such array according to claim 1, however, as interpreted in MPEP 2114 II and 2115, the courts have held the manner of operation nor material worked upon serve to distinguish an apparatus claim from the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-14,16-17 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10,12-18 of copending Application No. 18/025100.
Although the claims at issue are not identical, they are not patently distinct from each other because said present claims appear patentably indistinct minor methodical variations of all that is recited in the conflicting claims of ‘100 or, alternatively the subject matter claimed overlaps in scope to a large extent and, as a result the conflicting claims are rendered obvious.
The following is illustrative: regarding instant claims 2-9, said copending application is drawn to the same compatible solutes and organic solvents in the same concentrations (cf ‘100 claims 2-9); regarding instant claim 10 and ‘100 claim 10 are bot drawn to the same procedure; and regarding instant claim 11, ‘100 is drawn to the same salts (cf ‘100 claim 12).
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify embodiments of ‘100 that fall outside the scope of the present application to select a specifically disclosed embodiment that falls within the scope of the present application because each set of claims concern equipment and materials with similar physiochemical properties in that they all possess a common core structure both applied toward preventing undesirable biological activities such as crystal cracking upon ligand soaking. Furthermore, one of ordinary skill in the art would have been motivated to make such a modification because such modifications are disclosed as “preferred” since the dependent claims of ‘100 “teach toward” Applicant’s presently claimed techniques performed in the same array device.
This is a provisional obviousness-type double patenting rejection.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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/CHRISTOPHER M GROSS/
Primary Examiner, Art Unit 1684
1/9/2025