DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
2. Amendments filed August 11, 2026 are acknowledged.
3. Any rejections not explicitly maintained herein are withdrawn.
Status of Claims
4. Claims 1-18 and 20-33 are pending and under consideration.
New Claim Rejections - 35 USC § 112(a)
5. 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.
6. Claims 22-30 and 32-33 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
Applicant added new claims with new R1 elements and new chemical entities while stating support for the added claim limitation is found:
“Support for these amendments and new claims can be found in the application as originally filed. No new matter is added.”
As per MPEP 2163 II A: With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4 (Fed. Cir. 2007) (citing MPEP § 2163.04 which provides that a "simple statement such as ‘applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘___’ in the application as filed’ may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported."); see also MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure."); and MPEP § 2163.04 ("If applicant amends the claims and points out where and/or how the originally filed disclosure supports the amendment(s), and the examiner finds that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of the filing of the application, the examiner has the initial burden of presenting evidence or reasoning to explain why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims."). The inquiry into whether the description requirement is met is a question of fact that must be determined on a case-by-case basis. AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1297, 111 USPQ2d 1780, 1788 (Fed. Cir. 2014) ("Whether a patent claim is supported by an adequate written description is a question of fact."); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) ("Precisely how close [to the claimed invention] the description must come to comply with Sec. 112 must be left to case-by-case development."); In re Wertheim, 541 F.2d at 262, 191 USPQ at 96 (inquiry is primarily factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure).
The examiner could not locate support for such a new claim language, nor does there appear to be a written description of the limitation in the application as filed. See Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007) (holding that "[MPEP] § 2163.04 (I)(B) as written is a lawful formulation of the prima facie standard for a lack of written description rejection."). There is no literal support for the added limitation and one of skill in the art would not recognize that Applicant possessed the claim scope. Thus, the claims are rejected.
New Claim Rejections - 35 USC § 102
7. Applicant cannot rely upon the certified copy of the foreign priority application to overcome the following rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
8. 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.
(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.
9. Claims 1-18 and 20-33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ham et al. (Applicant cited in 2026-08-11 IDS EP4219474 which is English equivalent of WO2022092913 with EFD– citations to the English equivalent).
Ham claims a crystalline for of the same compound of Formula 1, including 5 or more characteristic peaks, as well as Fig. 4, which are within the instant claims:
PNG
media_image1.png
561
824
media_image1.png
Greyscale
as well as a pharmaceutical composition and a method for preparation. Thus, the claims are anticipated.
10. Claims 1-18 and 20-33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ham et al. (Applicant cited in 2026-08-11 IDS EP4219473 which is English equivalent of WO2022092910 with EFD– citations to the English equivalent).
Ham claims a crystalline for of the same compound of Formula 1, including 5 or more characteristic peaks, as well as Fig. 4, which are within the instant claims:
PNG
media_image2.png
641
928
media_image2.png
Greyscale
as well as a pharmaceutical composition and a method for preparation. Thus, the claims are anticipated.
11. Claims 1-18 and 20-33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ham et al. (Applicant cited in 2026-08-11 IDS EP4219475 which is English equivalent of WO2022092914 with EFD– citations to the English equivalent).
Ham claims a crystalline for of the same compound of Formula 1, including 5 or more characteristic peaks, as well as Fig. 4, which are within the instant claims:
PNG
media_image3.png
381
447
media_image3.png
Greyscale
PNG
media_image4.png
376
379
media_image4.png
Greyscale
as well as a pharmaceutical composition and a method for preparation. Thus, the claims are anticipated.
12. Claims 1-18 and 20-33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ham et al. (Applicant cited in 2026-08-11 IDS EP4219472 which is English equivalent of WO2022092909 with EFD– citations to the English equivalent).
Ham claims a crystalline for of the same compound of Formula 1, including 5 or more characteristic peaks, as well as Fig. 4, which are within the instant claims:
PNG
media_image5.png
609
927
media_image5.png
Greyscale
as well as a pharmaceutical composition and a method for preparation. Thus, the claims are anticipated.
Maintained Rejections
Claim Rejections - 35 USC § 112
13. 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.
14. Claims 1-18 and 20-33 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 1 reads “A crystalline form V of a compound of the following formula 1, wherein the crystalline form V has an X-ray powder diffraction (XRPD) pattern comprising characteristic peaks with diffraction angles …” with a list of 2-theta values and “wherein R1 is C2-C5 alkyl”. The 2-theta values are derived from the XRPD of Fig. 1 which the specification states is of Example 1 (Specification p. 28):
PNG
media_image6.png
516
623
media_image6.png
Greyscale
PNG
media_image7.png
343
596
media_image7.png
Greyscale
Thus, the 2-theta values only correspond to Example 1 which is not a salt or solvate thereof and only has R1 is isopropyl. As a result, one of skill in the art would find the claim confusing as to how multiple different compounds, salts, and solvates can ALL share the same XRPD peaks as per claim 1. For example, it is known in the art that small changes in structure cause large changes in XRPD 2-theta values as evidenced by Sivaramakrishna et al. (J. Chem. Sci. Vol. 127, No. 9, September 2015, pp. 1627–1635) in Figure 4 and Table 3 (p. 1633) which shows how the XRPD changes with the alkyl chain length “n”. Similarly, one of skill in the art would know that the different claim 1 R1 alkyl chains of varying length would result in different XRPD 2-theta peaks. Therefore, one of skill in the art would be uncertain as to what are the precise metes and bounds of the claims and the claim is indefinite.
As with claim 1, claims 2-7 are to a scope of R1, salts, and solvates such that the scope of the claims are unclear with respect to the 2-theta values. Claims 2-18 and 20-33 which depend from claim 1 are also rejected as indefinite as they incorporate and do not resolve claim 1’s indefiniteness.
Claims 17-18 is drawn to a pharmaceutical composition comprising the crystalline form and a carrier where the specification defines carrier as including solvents such as water, alcohols, ethers, oils, etc. which when combined with the crystalline form necessarily dissolves the form and the “composition” would be only the solution. One of skill in the art would find such claim language confusing as to whether the solution is being claims or only compositions where the crystalline form is maintained. Thus, the claims are indefinite. For purposes of examination, the claims are interpreted as where the crystal form is not dissolved in a solution.
Response to Remarks - 35 USC § 112
15. Applicant argues “the crystalline form V of the compound of formula 1 having 5 or more characteristic peaks in its X-ray powder diffraction pattern where R1 is C2-C5 alkyl, is clear and delineated to the skilled artisan”.
16. Applicant’s argument makes clear that the claim is indefinite by stating “there are only a small number of alkyl moieties having two to five carbons…” which is not sufficiently clear as to the metes and bounds of the claims because one of skill in the art could not determine which of the compounds actually fulfill the requirement. MPEP 2173.02 (During prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude. See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc) …. 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(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate. See IBSA Institut Biochimique, S.A. v. Teva Pharm. USA, Inc., 966 F.3d 1374, 1378-81, 2020 USPQ2d 10865 (Fed. Cir. 2020)). In this case, the record is ambiguous with respect to how different molecules (with different R1 groups and even salts or solvates thereof) would show the same characteristic peaks and nothing in the disclosure or Applicant’s remarks has clarified the issue such that the public would be on notice as to the metes and bounds of the claims. Rejection is maintained.
Claim Rejections - 35 USC § 103
17. 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.
18. 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.
19. Claims 1-7, 17-18, and 20-33 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (US20090298829).
Regarding claims 1-7, Choi teaches compounds that are agonists of melanocortin receptor (Title, Abstract, claim 1). Choi teaches Example A96 (Table 4, Table 18, claim 14):
N-[(3S,5S)-1-{[(3S,4R)-1-tert-butyl-4-(4-chlorophenyl)pyrrolidine-3-yl]carbonyl}-5-(morpholine-4-ylcarbonyl)pyrrolidine-3-yl]-N-(4,4-dimethylcyclohexyl)acetamide
PNG
media_image8.png
200
400
media_image8.png
Greyscale
and Example A7 ([0383], Table 18, claim 14):
(4S)-1-{[(3S,4R)-4-(4-chlorophenyl)-1-methylpyrrolidine-3-yl]carbonyl}-4-[(2,2-dimethylpropanoyl)(cis-4-methylcyclohexyl)amino]-L-prolineamide
PNG
media_image9.png
200
400
media_image9.png
Greyscale
Choi teaches the compounds are active in the experimental assay reported in Table 18 with EC50 values in the nM range ([0841]-[0848]).
Instant claims formula 1 includes the species having the following structure:
N-[(3S,5S)-1-[(3S,4R)-1-tert-butyl-4-(4-chlorophenyl)pyrrolidine-3-carbonyl]-5-(morpholine-4-carbonyl)pyrrolidin-3-yl]-N-(4-methylcyclohexyl)isobutyramide
PNG
media_image10.png
200
400
media_image10.png
Greyscale
Thus, claim 1’s compound differs from Choi’s A96 by a methyl group on the cyclohexyl ring and the alkyl homolog (methyl vs. isopropyl).
One of ordinary skill in the art following the teaching of Choi would have considered other compounds within Choi’s genus (claim 1) including the specific modifications of replacing the 4,4-dimethylcyclohexyl with a 4-methylcyclohexyl in view of the reported success with Choi’s Example A7 having the group. One of ordinary skill in the art would have also recognized that alkyl homologs including methyl and isopropyl could be interchanged and maintain activity in view of A7’s homologous alkyl – MPEP 2144.09. One of ordinary skill in the art would have had a reasonable expectation of success because Choi teaches the genus encompassing the instant claims and because Choi teaches the structurally similar compounds as demonstrating activity.
Regarding the crystalline form language of the instant claims, Choi teaches preparation of the compound in the same manner as in the instant application but does not disclose the XRPD data. However, such properties are inherent in the product and are inseparable as stated in MPEP 2112.01:
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
…
“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
In this case, the structure of the modified product is identical to the instant claims and is produced in a substantially identical process. Thus, a prima facie case of obviousness has been established and the claim rejected.
Regarding claims dependent claims, Choi teaches A7 as an HCl salt and also claims pharmaceutically acceptable salts together with a pharmaceutically acceptable carrier which one of ordinary skill in the art would consider in formulating the pharmaceutical as is routinely done in the art and arrive at the claimed invention.
Regarding claims 20-21 to a method of agonizing the function of melanocortin-4 receptor, Choi teaches the same utility (title, abstract, claims 16-19), including for obesity such that one of ordinary skill in the art would have used the compound in the same manner and arrive at the claimed invention.
20. Claims 1-18 and 20-33 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (US20090298829) in view of Carlson et al. (US20030124028), Gardner et al. (Computers and Chemical Engineering 28 (2004) 943–953).
Choi teaches as in the 35 USC 103 rejection supra and incorporated herein. Choi does not specifically teach a crystal form or specific methods of making a crystal form.
Carlson teaches well-known systems for automated high-throughput preparation and screening of salts and polymorphs of drug candidates (emphasis added):
PNG
media_image11.png
462
1022
media_image11.png
Greyscale
(Carlson Abstract). Carlson’s system specifically screens for polymorphs using a variety of techniques and solvents including water, methanol, acetonitrile, MTBE, ethylene glycol, THF, and DMSO (claim 1, [0019], [0143]-[0144], [0157]-[0177], Fig. 29)
Carlson’s system is similar to commercially available systems such as CRYSTALMAX as discussed by Gardner (Gardner p. 947-949 “6.”, Figs. 4 and 5 describing CRYSTALMAX) including Gardner’s demonstrated success with salt forms of sulfathiazole (p. 950 “6.1.3”, Fig. 10) and polymorphic forms of Ritonavir (Gardner p. 949 “6.1.1”). Given the high level of skill in the art as evidenced by Choi, Carlson and Gardner, one of ordinary skill in the art would have considered the application of Carlson’s technique using a commercially available system (such as Gardner’s) on Choi’s compound as “routine optimization” because it was well-known, commercially available, and was a routine part of drug discovery (Gardner p. 944-45, Figs. 2-3).
One of ordinary skill in the art would have had a reasonable expectation of success in producing the solid forms of Choi’s modified compound because Carlson and Gardner teach successful application to pharmaceuticals using the well-known and technique (Carlson [0091], [0110], [0124]-[0126]) including particular solvents and conditions (Carlson [0163]-[0165], [0261], Fig. 29), varying temperatures (Carlson [0026], [0138]-[0150], claims 43, 55-56), and seeding (Carlson [0141]). These conditions correspond to the same process as disclosed in in the instant specification.
As in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) (“When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103.”), one of ordinary skill in the art would have known about the need to select the optimal form of the drug identified by Choi, including the specific salt and polymorphic forms which were known to be predictably discoverable by application of Carlson’s technique and was also within one of ordinary skill in the art’s technical grasp as evidenced by the commercially available system taught by Gardner. Thus, it would have been obvious to try and one of ordinary skill in the art would have anticipated success in the endeavor.
At the time of invention, there was an art recognized need to identify the optimal solid form of a pharmaceutical as established by Carlson, and Gardner (Carlson [0004]-[0005], [0010]-[0011]; Gardner Fig. 2, Fig. 5, p. 944-946, “3.1”, “3.2”, “3.3”). The commercially available automated system that identifies “substantially every polymorph” evidenced by Carlson and Gardner provided a predictable solution to the problem of pharmaceutical solid forms. One of ordinary skill in the art would have pursued the commercially available system with a reasonable expectation of success because the systems were known to identify “substantially every polymorph” (Carlson Abstract) and Gardner demonstrated success with the commercial system (Gardner p. 947-950 “6.”, “6.1.1”, “6.1.3”, Figs. 4 and 5 describing CRYSTALMAX). Similarly, one of ordinary skill in the art would have applied the known technique of pharmaceutical solid form optimization (Carlson; Gardner) to the known product of Choi that would have yielded the predictable result of the optimal pharmaceutical solid form. Alternatively, one of ordinary skill in the art would have used the known technique that successfully identified the optimal solid form of other pharmaceuticals demonstrated by Gardner (sulfathiazole p. 950 “6.1.3”, Fig. 10; Ritonavir p. 949 “6.1.1”) and applied the known optimization technique in the same way to Choi’s compound where the result would have been predictable due to the explicit teaching of Carlson that the techniques was known to identify “substantially every polymorph”.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art in the same field of endeavor. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success.
Therefore, the claims are rejected as prima facie obvious.
Response to Remarks - 35 USC § 103
21. Applicant argues that Choi discloses a genus of compounds and none of the particular Choi compounds are embraced by the claimed formula I. This is not persuasive because Choi claims compounds A7 and A96 in claim 14 which, as detailed above, are an obvious alkyl homologs including methyl and isopropyl could be interchanged and maintain activity in view of A7’s homologous alkyl – MPEP 2144.09.
22. Applicant argues that Choi, Carlson, and Gardner, that the skilled artisan would not be motivated to make any combination to arrive at the instant crystalline form I and have a reasonable expectation of success in doing so. This argument is not persuasive because Choi teaches the species A7 and A96, both of which are claimed, and Choi teaches the compounds of the invention are active in the experimental assay reported in Table 18 with EC50 values in the nM range ([0841]-[0848]). Choi further teaches preparing the compounds by conventional crystallization ([0064]) as one of ordinary skill in the art would routinely do. One of ordinary skill in the art would also consider the well-known process of polymorph screening as detailed in Carlson and Gardner to optimize the physical properties of the pharmaceutical stability and solubility (i.e. Gardner Fig. 2). Thus, one of ordinary skill in the art was highly motivated to discover the solid forms of a pharmaceutical and would have utilized the process taught by Carlson with a “systems for performing high-throughput preparation and screening of salts and polymorphs of drug candidates” (Carlson Abstract), using a commercially available system such as taught by Gardner. Thus, one of ordinary skill in the art was motivated and had a reasonable expectation of success.
23. Applicant argues that none of the particular compounds disclosed in Choi are embraced by the claimed formula I per se, let alone is there any disclosure of a crystalline form I characterized by 5 or more X-ray powder diffraction peaks as recited in the claims, and the prior art is silent as to the claimed crystalline form I having 5 or more characteristic X-ray powder diffraction peaks. This argument is not persuasive because these are inherent properties of the obvious product that would necessarily be present in the product produced by the obvious process.
24. Applicant argues “Table 18 of Choi, which provides the half-maximal effective concentrations (EC so values) for the melanocortin-4 receptor (MC4R) for Compounds A96 and A7 and a minority of other compounds … does not provide any guidance or teaching for arriving at the claimed compound”. This argument is not persuasive because one of ordinary skill in the art would have recognized that alkyl homologs would be expected to share the same properties as demonstrated by the prior art. In addition, patents are relevant as prior art for all they contain, including among alternative embodiments such as Choi’s compounds shown to be active. MPEP 2123 (“[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004)). Rejections maintained.
Double Patenting
25. 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.
26. Claims 1-18 and 20-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 7879852 in view of Choi et al. (US20090298829), Carlson et al. (US20030124028), Gardner et al. (Computers and Chemical Engineering 28 (2004) 943–953). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims the same species as Choi and are obvious for the same reasons provided in the 35 USC 103 rejection supra.
27. Claims 1-18 and 20-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of the following copending Application Nos. (reference applications) in view of Choi et al. (US20090298829), Carlson et al. (US20030124028), Gardner et al. (Computers and Chemical Engineering 28 (2004) 943–953). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference applications claim the same species as the instant claims and are obvious for the same reasons provided in the 35 USC 103 rejection supra.
Reference applications:
17619893
18251101
18251084
18251129
18251111
18258705
18258711
18258730
18258717
18588142
18558148
18558351
18558812
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Remarks - Double Patenting
28. Applicant requests that the rejection be held in abeyance until there is an indication of allowable subject matter. Thus, the rejections are maintained.
Conclusion
29. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha Shterengarts whose telephone number is (571)270-5316. The examiner can normally be reached on Monday thru Thursday 9-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
30. 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 extension fee 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.
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
Prosecution Insights