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 .
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.
Previously presented rejection of claims 5-8, 10 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 is maintained for reasons of record.
Applicants arguments focus on amendments to claims, disclosure in the specification, specifically working Examples 6 and 7 and the number of peaks.
Amendments to base claim 5 relating to number of peaks and clarification with regards with regards to peak position with error limits are persuasive partially.
The argument at Remarks page 6
PNG
media_image1.png
74
558
media_image1.png
Greyscale
is confusing in that it requires importing limitations from the specification into the claim.
This further raises clarity issue, as it is unclear if the peak positions is characteristic of one single crystalline form.
As previously acknowledged making crystalline forms (with differing characteristic diffraction parameters) of previously known compound is routine in the art. The issue here which form protection is sought for. As pointed out in the previous action at page 4 and further at top of page 5, peak position limiting the base claim 5 WITHOUT relative peak intensity could be accommodated for crystalline which provides for FIG 2a. As per claim 8, Figure 8 defines the unique crystalline form of 5. However the peak position in the claim 5 are also in the FIG 2a.
From previous action:
The claims are drawn to
PNG
media_image2.png
148
726
media_image2.png
Greyscale
In this case,
PNG
media_image3.png
30
368
media_image3.png
Greyscale
not
PNG
media_image4.png
16
134
media_image4.png
Greyscale
in sufficient
PNG
media_image5.png
18
94
media_image5.png
Greyscale
therefore the ‘claimed invention’ not
PNG
media_image6.png
24
118
media_image6.png
Greyscale
The claim is drawn to a crystalline form that is defined with x-ray diffraction pattern that has too little information. The base claim 5 is drawn to a diffraction pattern ‘substantially’ as in Figure 8. The ‘approximate’ positions, with acknowledged errors, in claim 5 overlaps extensively with those disclosed for many other crystalline forms disclosed in the specification.
Compare for example Figure 8 with Figure 2a relating to two different forms of the same compound. These two Figures according to the disclosure are drawn to two different crystal forms made by two different processes. However, one of skill in the art could easily identify peak positions defined in claim 5 in the peaks of Figure 2a.
The following are FIG 8 corresponds to dependent claim 8 and FIG 2a (corresponds to different crystal form):
PNG
media_image7.png
292
848
media_image7.png
Greyscale
But for the peak intensity around that theta 10, in Fig. 8, comparison of the above two Figures show that there is insufficient information present in claim 5 to identity what crystal form protection is sought for.
All the peak positions in Fig 2a and in of Fig 8
PNG
media_image8.png
38
290
media_image8.png
Greyscale
could be overlapped; the peaks positions, mostly noise, overlaps with disclosed for other crystalline forms in the disclosure.
The process of making the claimed crystalline form disclosed in US 20240199573 is revealing and discussed below.
Relevant portions at page 18 [0287] onto page 19 [0291].
Example 6, the carboxamide (30 mg) in 50/50 methanol/water (100 μL) was matured by temperature cycling for 2 days. The resulting solids were isolated to afford (Form 3).
[0288] An XRPD diffractogram of (Form 3) is shown in FIG. 8.
Example 7— (Form 4)
[0290] A suspension of the carboxamide (20 mg) in 50/50 methanol/water (100 μL) was heated. Not all of the solid dissolved and therefore the mixture was filtered. The filtrate was allowed to evaporate under nitrogen to afford (Form 4).
[0291] An XRPD diffractogram of is shown in FIG. 9.
Shown below are Figure 8 and Figure 9
PNG
media_image9.png
294
856
media_image9.png
Greyscale
As found in Examples 6 and 7, different crystals forms showing very different diffraction patterns are made by very similar process procedures. Note that same amount of, same mixture of solvent is used to make vastly different crystals. In Example 6, vaguely defined process temperature cycling) is used to dissolve 30 mg of the carboxamide. In Example 7, the same solvent is insufficient to dissolve 20 mg. In Example 6, 100 μL, presumably dissolves 30 mg, but cannot dissolve 20 mg in Example, 7, raising questions regarding, ‘matured by temperature cycling’ in Example 6 means. The phrase ‘temperature cycling’ is vaguely and broadly defined at page 11, [0195]: The temperature cycling may comprise cycling the temperature of the mixture between about 30-50° C. and ambient temperature, optionally between about 40° C. and ambient temperature. Preferably, the temperature cycling is carried out for between about 18 to about 24 hours. The open-ended comprising language used here to describe the ‘cycling the temperature’ further renders the working example insufficient for 112-1 requirement
PNG
media_image10.png
200
400
media_image10.png
Greyscale
As taught in Braga, D., Chem. Asian J. Vol. 6, pp 2214-2223) 2011, column A, page 2222, it is still simply not possible to predict whether a given molecule will crystallize from solution in one or many crystal forms. Braga concludes
PNG
media_image11.png
170
328
media_image11.png
Greyscale
The specification does not disclose any other physical parameters for the claimed crystal.
As such
PNG
media_image12.png
84
748
media_image12.png
Greyscale
While it is acknowledged that ‘multitudes of crystalline forms’ can be made for the same compound (see Chapter 1, page 1 of Brittain, Polymorphism in Pharmaceutical Solids, col.12, 2009), and that it is generally sufficient for the scattering angles of the 10 peaks strongest peaks to agree (within acceptable error) to identify two crystals as being the same (see page 334 of Brittain), without additional characterizing physical parameters such as DSC or mp numbers, few peaks of claim 5 (without relative intensity in diffraction pattern) are not sufficient to differentiate the crystal Form 3 from several crystalline forms disclosed in the specification. Note that although the claims are interpreted in light of the specification, limitations from the specification (such as those in [289} Table or claim 8) are not read into the claim 5. The limitations of claim 5, does not require that the crystalline form be Form 3. The listed peaks are not sufficient to describe this one and therefore raises scope issues for claim 5. In the alternate, considering the breadth of claim 5, the specification does not teach how to make other crystal forms other than Form 3 (as per Figure 8) with the indicated peaks (in claim 5). Further dependent claim 9, raises issues of enablement since the crystalline structure must be maintained in the composition (since the crystalline form will lose its defining structure in, for example, a liquid composition). The specification does not teach how to make the crystal Form 3 in predictable manner.
MPEP 2164.01(a) states, “A conclusion of Iack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the invention of claim 5 without undue experimentation. ln re Wright, 999 F.2d 1557,1562, 27 USPQ 2d 1510, 1513 (Fed. Cir. 1993).'' That conclusion is clearly justified here. Thus, undue experimentation would be required to make and use Applicants' invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent 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”.
or in vivo.
The prior art made of record with regards to unpredictability in the art, and not relied upon is considered pertinent to applicant's disclosure.
Chan, Phys. Chem. Chem. Phys., 2011, 13, 20361–20370, Predictability of the polymorphs of small organic compounds.
Jiang, Journal of Crystal Growth 523 (2019) 125150, Effects of solvents and impurity on crystallization kinetics and crystal properties.
Liu, Cryst. Growth Des. 2023, 23, 5846−5859 The Influence of Solvent Selection upon the Crystallizability..
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Previously presented rejection of claim 10 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11230537 is maintained.
PNG
media_image13.png
44
628
media_image13.png
Greyscale
From previous action:
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing
Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804.
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32 (2010) 324–330.
.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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, Andrew Kosar can be reached at (571) 272-0913. 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.
/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625