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 .
Claims 1-4, 6, 7 and 9-20 are pending in this application.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the relative intensity of 100 % for peak 12.65 of Figure 1; the relative intensity of 100 % for peak 12.66 of Figure 4 as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Table 1 indicates 100.00 % relative intensity for peak 12.65; and
Table 2 indicates 100.00 % relative intensity for peak 12.66.
Appropriate correction is required.
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 4, 7 and 9-20 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. The following reasons apply:
Claim 4 recites the broad recitation in terms of 2θ angle, at 7.77±0.20°, 8.70±0.20°, 11.49±0.20°, 18.22±0.20°, and 23.39±0.20°; and the claim also recites at least 5, 6, 7, or 8 diffraction peaks, in terms of 2θ angle, selected from the group consisting of: 7.77±0.20°, 8.70±0.20°, 11.49±0.20°, 13.45±0.20°, 18.22±0.20°, 19.82±0.20°, 21.88±0.20°, and 23.39±0.20°; or, recites in terms of 2θ angle, at 7.77±0.20°, 8.70±0.20°, 11.49±0.20°, 13.45±0.20°, 18.22±0.20°, 19.82±0.20°, 21.88±0.20°, and 23.39±0.20°; or, recites 12, 13, 14, 15 , or 16 diffraction peaks, in terms of 2θ angle, at 7.77±0.20°, 8.70±0.20°, 9.97±0.20°, 10.64±0.20°, 11.49±0.20°, 13.45±0.20°, 15.55±0.20°, 18.22±0.20°, 19.82±0.20°, 20.37±0.20°, 21.88±0.20°, 23.39±0.20°, 23.99±0.20°, 27.29±0.20°, 27.75±0.20°, and 31.35±0.20°; or, recites in terms of 2θ angle, at 7.77±0.20°, 8.70±0.20°, 9.97±0.20°, 10.64±0.20°, 11.49±0.20°, 13.45±0.20°, 15.55±0.20°, 18.22±0.20°, 19.82±0.20°, 20.37±0.20°, 21.88±0.20°, 23.39±0.20°, 23.99±0.20°, 27.29±0.20°, 27.75±0.20°, 31.35±0.20°; each of which is a narrower statement of the limitation from the previous. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 7 recites the broad recitation in terms of 2θ angle, at 8.53±0.20°, 9.67±0.20°, 10.31±0.20°, and 15.14±0.20°, and the claim also recites in terms of 2θ angle, selected from the group consisting of: 8.53±0.20°, 9.67±0.20°, 10.31±0.20°, 15.14±0.20°; and 17.03±0.20°; or, recites at least 5, 6, 7, or 8 diffraction peaks, in terms of 2θ angle, at 8.53±0.20°, 9.67±0.20°, 10.31±0.20°, 11.86±0.20°, 15.14±0.20°; 17.03±0.20°, 19.07±0.20°, and 23.60±0.20°; or, recites in terms of 2θ angle, at 8.53±0.20°, 9.67±0.20°, 10.31±0.20°, 11.86±0.20°, 15.14±0.20°; 17.03±0.20°, 19.07±0.20°, and 23.60±0.20°; or, recites 10, 11, 12, or 13 diffraction peaks, in terms of 2θ angle, at 8.53±0.20°, 9.67±0.20°, 10.31±0.20°, 11.86±0.20°, 15.14±0.20°; 16.67±0.20°, 17.03±0.20°, 18.50±0.20°; 19.07±0.20°, 21.12±0.20°, 23.60±0.20°, 26.61±0.20°, and 29.58±0.20°; or, recites in terms of 2θ angle, at 8.53±0.20°, 9.67±0.20°, 10.31±0.20°, 11.86±0.20°, 15.14±0.20°; 16.67±0.20°, 17.03±0.20°, 18.50±0.20°; 19.07±0.20°, 21.12±0.20°, 23.60±0.20°, 26.61±0.20°, and 29.58±0.20°; each of which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 9 recites the broad recitation in terms of 2θ angle, at 9.50±0.20°, 15.79±0.20°, and 18.44±0.20°, and the claim also recites in terms of 2θ angle, 9.50±0.20°, 13.34±0.20°, 15.79±0.20°, 18.44±0.20°, and 24.43±0.20°; or, recites at least 5, 6, 7, or 8 diffraction peaks, in terms of 2θ angle, at 9.50±0.20°, 13.34±0.20°, 15.79±0.20°, 18.44±0.20°, 19.97±0.20°, 21.27±0.20°, 21.80±0.20°, and 24.43±0.20°; or, recites in terms of 2θ angle, at 9.50±0.20°, 13.34±0.20°, 15.79±0.20°, 18.44±0.20°, 19.97±0.20°, 21.27±0.20°, 21.80±0.20°, and 24.43±0.20°; each of which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 10 and claims dependent thereon are vague and indefinite in that it is not known what is meant by “formula (I)” where there is no formula (I) in independent claim 10.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation 0.9 to 1.1, and the claim also recites 0.9, 1 or 1.1 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 12 recites the broad recitation in terms of 2θ angle, at 11.64±0.20°, 18.51±0.20°, and 22.68±0.20°, and the claim also recites in terms of 2θ angle, 4.62±0.20°, 11.64±0.20°, 13.24±0.20°, 18.51±0.20°, and 22.68±0.20°; or, recites at least 6, 7, or 8 diffraction peaks, in terms of 2θ angle, at 4.62±0.20°, 10.98±0.20°, 11.64±0.20°, 13.24±0.20°, 16.76±0.20°, 18.51±0.20°, 22.68±0.20°, and 23.52±0.20°; or, recites in terms of 2θ angle, at 4.62±0.20°, 10.98±0.20°, 11.64±0.20°, 13.24±0.20°, 16.76±0.20°, 18.51±0.20°, 22.68±0.20°, and 23.52±0.20°; or, recites at least 12, 13, 14, 15, or 16 diffraction peaks, in terms of 2θ angle, at 4.62±0.20°, 9.80±0.20°, 10.98±0.20°, 11.64±0.20°, 12.63±0.20°, 13.24±0.20°, 13.79±0.20°, 15.28±0.20°, 16.76±0.20°, 18.51±0.20°, 19.62±0.20°, 21.62±0.20°, 22.68±0.20°, 23.52±0.20°, 25.04±0.20°, and 26.64±0.20°; or, recites in terms of 2θ angle, at 4.62±0.20°, 10.98±0.20°, 11.64±0.20°, 13.24±0.20°, 13.79±0.20°, 15.28±0.20°, 16.76±0.20°, 18.51±0.20°, 19.62±0.20°, 22.68±0.20°, 23.52±0.20°, and 26.64±0.20°; or, recites in terms of 2θ angle, at 4.62±0.20°, 9.80±0.20°, 10.98±0.20°, 11.64±0.20°, 12.63±0.20°, 13.24±0.20°, 13.79±0.20°, 15.28±0.20°, 16.76±0.20°, 18.51±0.20°, 19.62±0.20°, 21.62±0.20°, 22.68±0.20°, 23.52±0.20°, 25.04±0.20°, and 26.64±0.20°; each of which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 13 recites the broad recitation in terms of 2θ angle, at 11.56±0.20°, 18.64±0.20°, and 22.52±0.20°, and the claim also recites in terms of 2θ angle, 10.01±0.20°, 11.56±0.20°, 13.07±0.20°, 18.64±0.20°, and 22.52±0.20°; or, recites at least 6, 7, or 8 diffraction peaks, in terms of 2θ angle, at 10.01±0.20°, 11.56±0.20°, 13.07±0.20°, 14.17±0.20°, 18.64±0.20°, 20.06±0.20°, 22.52±0.20°, and 23.48±0.20°; or, recites in terms of 2θ angle, at 10.01±0.20°, 11.56±0.20°, 13.07±0.20°, 14.17±0.20°, 18.64±0.20°, 20.06±0.20°, 22.52±0.20°, and 23.48±0.20°; or, recites at least 12, 13, 14, 15, or 16 diffraction peaks, in terms of 2θ angle, at 4.29±0.20°, 10.01±0.20°, 10.89±0.20°, 11.56±0.20°, 13.07±0.20°, 14.17±0.20°, 14.80±0.20°, 15.66±0.20°, 16.37±0.20°, 18.64±0.20°, 20.06±0.20°, 22.52±0.20°, 23.48±0.20°, 24.80±0.20°, 25.98±0.20°, and 29.35±0.20°; or, recites in terms of 2θ angle, at 4.29±0.20°, 10.01±0.20°, 10.89±0.20°, 11.56±0.20°, 13.07±0.20°, 14.17±0.20°, 16.37±0.20°, 18.64±0.20°, 20.06±0.20°, 22.52±0.20°, 23.48±0.20°, and 25.98±0.20°; or, recites in terms of 2θ angle, at 4.29±0.20°, 10.01±0.20°, 10.89±0.20°, 11.56±0.20°, 13.07±0.20°, 14.17±0.20°, 14.80±0.20°, 15.66±0.20°, 16.37±0.20°, 18.64±0.20°, 20.06±0.20°, 22.52±0.20°, 23.48±0.20°, 24.80±0.20°, 25.98±0.20°, and 29.35±0.20°; each of which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1 and 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 13-16 and 18-20 of U.S. Patent No. 12,590,082. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds, compositions and method of use of the compound of formula (IV-1) where T1 is N(CH3); B is cyclohexyl, R1 is H and (R2)n is H are embraced by the compounds, compositions and method of use of the compound of formula (I) as claimed herein.
The references show the compound of in claim 16, first species, but are silent on the particular crystallographic form. MPEP 2112 states:
“SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY
The claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
In this case, the “unknown property” is the particular crystalline form. This is unknown because the reference is silent on this property. MPEP 2112 goes on to state:
“A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTIC
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection.”
Again, the “CHARACTERISTIC” which the prior art is silent on is the crystalline form (crystalline form is considered to be in the category of chemical properties; see Zenith Laboratories Inc. v. Bristol-Myers Squibb Co. 30 USPQ2d 1285, 1288).
This is not an ordinary inherency situation where it is not explicitly stated what the product actually is. In every reference applied, the reference explicitly teaches exactly what the compound is. In fact, it is the opposite. In a normal inherency situation, the claim is of known structure, and the reference is of unknown structure. Here, the latter is not true, and hence the legal circumstances of inherency in the prior art do not apply. The only difference is the property about which the reference happens to be silent. Recitation of a property, inherently possessed by the prior art thing, does not distinguish a claim drawn to those things from the prior art, In re Swinehart, 169 USPQ 226, 229.
See for example Ex parte Anderson, 21 USPQ 2d 1241 at 1251, discussion of Rejection E. The claims had “numerical or functional values for certain properties which [the authors of the references] did not measure”. The PTO presented no reasoning as to why the prior art material would have been expected to have those properties. Instead, the decision states, “There is ample precedent for shifting the burden to an applicant to reproduce a prior art product whose final structure or properties are, at least, in part determined by the precise process used in its manufacture.” (page 1253).
In another example, certain claims of Ex parte Raychem Corp. 25 USPQ2d 1265 required a linearity ratio of less than 1.2. The decision notes that neither reference discloses any values of the linearity ratio. The PTO presented no reasoning as to what the ratio would be expected to be in the references. The Decision states: “However, this does not end the inquiry since, where the Patent and Trademark Office is not equipped to perform the needed testing, it is reasonable to shift the burden of proof to Raychem to establish that (1) the argued difference exists….”
And indeed, there have been a number of cases in which applicants have pointed to silence of the prior art with regard to this or that property: In re Pearson, 181 USPQ 641; In re Zierden 162 USPQ 102; In re Lemin, 140 USPQ 273; Titanium Metals Corporation of America v. Banner, 227 USPQ 773; In re Benner, 82 USPQ 49; In re Wilder, 166 USPQ 545; Ex parte Kucera, 165 USPQ 332; General Electric Co. v. Jewel Incandescent Lamp Co., 67 USPQ 155; In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607; In re Parker, 43 USPQ 457. Such efforts to avoid anticipation on that basis invariably failed. Going further, if silence about properties of prior art compounds could be relied on, then one could not reject over references with no utility (see in re Schoenwald, 22 USPQ2d 1671), since applicants could always insert the utility into the claim as a property.
It is well settled that the PTO can require an applicant to establish that a prior art product does not necessarily possess the characteristics of the claimed product when the prior art and claimed products are identical or substantially identical. An applicant's burden under these circumstances was described in In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-434 (CCPA 1977) as follows:
Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on ‘inherency' under 35 U.S.C. § 102, or ‘prima facie obviousness’ under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products (footnote omitted).
Overcoming the rejection is very straightforward. One simply replicates the prior art procedure. If the claimed characteristic does not appear at all in the product, or if on repetition, it sometimes does not appear in the product, then the rejection is overcome.
If applicants reasoning were accepted, an old compound could always be re-patented, by the simple expedient of isolating the compound in a different manner. All such would be patentee would need to do is attach some parameter which the original patent had been silent about, and there will almost always be such a parameter. For example, suppose a person were to use some solvent anti-solvent pair which applicants didn’t happen to use, and obtained one of applicants’ forms. The person would then write the claim for the compound, using some parameter which applicants didn’t happen to mention, such as density. According to applicants reasoning, the different method of crystallization, along with the instant specification’s silence on density, should prevent any anticipation rejection. The next person could come around with yet another solvent/anti-solvent pair (or some other method) which happened to produce the same form, and this time label it with the gross crystalline habit (e.g. flakes, needles, dendritic, cubic, etc.), which neither of the previous two patentees had mentioned. The fourth inventor could again re-patent the same material, this time tacking on a melting point limitation, pointing to the different method and silence on this characteristic, and the fifth inventor could label the form by refractive index (or dielectric constant), and the sixth could use the enthalpy of melting (i.e. latent heat of melting or “heat of fusion”). Yet another person could specify the maximum level of water or some other solvent, unreacted starting material, or indeed any impurity, previously known or unknown, which the reference happened to be silent about.
Claims 1 and 14-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-25, 31 and 32 of copending Application No. 2026/0200904 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds, compositions and method of use of the compound of formula (III-1) where T1 is N(CH3); L1 is a single bond; B is cyclohexyl, R1 is H and (R2)n is H (see the compound of claim 25) is embraced by the compounds, compositions and method of use of the compound of formula (I) as claimed herein and the reasons set forth above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claims 2, 3 and 6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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, Jeffrey H. Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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