DETAILED ACTION
The receipt is acknowledged of applicant’ amendment filed 09/30/2025.
Claims 97-99, 107, 109, 130-143 previously presented. claims 98, 107, 109, 130-132, and 143 are currently canceled. Claims 97, 99, 133-142 are pending and subject of this office 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 .
Claim Rejections - 35 USC § 112(a)
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 97, 99, 133-142 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 97 recites “organic compound having molecular weight of less than or equal to 1000 gm/mol” and claims 139-140 recite broad categories of and classes of compounds which are very broad genus comprise myriad of species that may have molecular weights outside the claimed molecular weight. The specification gives no guidance to one of ordinary skill in the art regarding which organic compound within the claimed genus can sublimate and can be used in the claimed method of organic vapor jet printing (OVJP). The specification does not describe what organic compounds that are capable of sublimation and dissolving in what solvents present in liquid target. The recited organic compounds without partial or complete description of which compounds can be sublimated to be used in the claimed method does not convey to one of ordinary skill in the art that applicants were in possession of the claimed subject matter. The broad disclosure of organic compounds do not meet the written description requirement for the claimed limitations as one of ordinary skill in the art could not recognize or understand what of the claimed organic compounds, known and unknown, can be sublimated because not all organic compounds embraced by the recited genus claimed by claims 97, 139-140 have the claimed molecular weight or can be sublimated under the same conditions of the claimed method and deposited and dissolve in a liquid target comprising solvent(s). Not all the claimed organic compound can dissolve in aqueous solvents, polar, non-polar solvents claimed by claims134-138. Further, some of organic compounds fall within the scope of claims, e.g. claim 139, have molecular weight less than even that claimed by claim 41 of 100-900 g/mol. For example claim 139 recites free radical scavenger”, and e.g. of compounds fall under this category is hydrogen peroxide that has molecular weight of 34 g/mol. Further, claim 140 recites anticoagulants that include agent having compounds with molecular weight more than 1000 as claimed by claims 97 and 142, e.g. low molecular weight heparin has molecular weight of 4000-5000 g/mol that above the claimed molecular weight.
Claims’ limitations at the point of novelty, such as applicants’, neither provide those elements required to practice the inventions, nor “inform the public” during the life of the patent of the limits of the monopoly asserted. The claimed organic compound genus could encompass myriad of compounds, known and unknown and applicants claimed expressions in the context of the claimed method represents only an invitation to experiment regarding possible organic compounds encompassed by the claims and are suitable for the claimed method. Applicants disclosed several methods, other than the claimed OVJP, and it is not disclosed which organic compounds are suitable for which method. The disclosure does not assure one skilled in the art that all the broad range of genus of chemical compounds would have the claimed molecular weight, can sublimate, and dissolve in the liquid target.
Regarding the requirement for adequate written description of pharmaceuticals and chemical entities, Applicants' attention is directed to MPEP § 2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F. 3d 1559, 1568 (Fed. Cir. 1997), cert denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish list or plan for obtaining the claimed chemical invention." Eli Lilly, 119 F. 3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the U.S.C. 112.1 "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including inter alia, "functional characteristics when coupled with a known or disclosed correlation between function and structure..." Enzo Biochem Inc. v. Gen-Probe Inc., 296 F. 3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. At 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v. G.D. Searle & Co., 249 Supp. 2d 216,225 (W.D.N.Y. 2003).
To satisfy the written description requirement, the applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed. Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed.Cir.2008) (quoting In re Alton, 76 F.3d 1168, 1172 (Fed.Cir.1996)). In other words, the applicant must `convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and demonstrate that by disclosure in the specification of the patent.
Written description requirement, serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed. Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed.Cir. 2005). The requirement serves a teaching function, as a quid pro quo in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time. (Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed.Cir.2004) (quoting Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed.Cir.2002)). A patentee can lawfully claim only what he has invented and described, and if he claims more his patent is void; Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed.Cir.2000). The purpose of the written description requirement is to ensure that the scope of the right to exclude and does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods. Where the specification provides only constructive examples in lieu of working examples, it must still "describe the claimed subject matter in terms that establish that the applicant was in possession of the claimed invention, including all of the elements and limitations." Id. (citing Hyatt v. Boone, 146 F.3d 1348, 1353 (Fed.Cir. 1998)).
Further, it has been held that In Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996), a (“laundry list” disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species).
A genus such as "pharmaceutical agents categories, chemical entities and new chemical entities" can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus that can be used in the claimed method. If the genus has substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not specifically define what constitutes a representative number of species, courts have indicated what does not constitute same. See, e.g., In re Gostelli, 10 USPQ 2d 1614, 1618 (Fed. Cir. 1989), holding that the disclosure of two compounds within a subgenus did not adequately describe such subgenus. The instant specification does not describe specific "organic molecules" that can be sublimated by heat and used in the claimed OVJP under the claimed conditions. Accordingly, the expressions "organic compounds" as used currently by instant claims are deemed so indistinct that it fails to reasonably convey to one skilled in the art that applicant was in possession of a representative number of species within that genus.
Federal Circuit decision in Ariad Pharmaceuticals, Inc v. Eli Lilly. 598 F. 3d 1336 - Court of Appeals, Federal Circuit, 2010 – It explains that the written description requirement applies to both original and amended claims. It had further explained that the test for written description is “possession as shown in the disclosure” and embraced past ways for judging the adequacy of the disclosure, including whether the specification discloses a representative number of species, sufficient structure, and/or a sufficient correlation of function to structure.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984). (Holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.’)
Claim Rejections - 35 USC § 112(b)
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 97, 99, 133-142 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.
Regarding claim 97, the claim is confusing as it recite:”….target liquid comprising one or more solvent….”, because it is not clear if the target liquid is the solvent, or the solvent is a separate ingredient present in the target liquid.
Further, claim 97 recites “less than or equal to 1000 g/mol” without lower limit to the claimed molecular weight.
Claim 99 recites the limitations "the condensed" and “of the surface” in fourth and fifth lines, respectively. There is insufficient antecedent basis for this limitation in the claim or in claim 97 from which the claim depends.
Claim 133 recites the limitation "the condensed" in second line of the claim. There is insufficient antecedent basis for this limitation in the claim or in claim 97 from which the claim depends.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./