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 1-32, pending in this application, are examined.
Copending Applications
Applicants must bring to the attention of the Examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 102 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, starting with Application No. 15/486, 737, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The word “dicot” or “dicotyledonous”, or even a single species of dicot plant is not even mentioned in the parent applications. Therefore, claims 1-32 requiring “pollen from dicotyledonous plant” is neither described nor enabled in the parent applications. Therefore, the effective filing date of the instant application 18/740, 733 is considered to be 06/12/2024.
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 1-21 and 25-30 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.
At paragraph [0054], “pollen field conditioning” or “field conditioning” is used to describe “the process disclosed in this application of treating freshly-collected pollen in the field to maintain or improve its viability, allowing for more successful pollen storage”.
It is unclear how “the temperature and relative humidity are adjustable” (claims 1 and 8); and how “a flow of one or more continuously refreshed, selected gases” (claims 2, 7, 9, and 14), since the pollen conditioning is conducted in the field, according to paragraph [0054] of the specification. Clarification is required to more clearly define the metes and bounds of the claims. Dependent claims 3-6 and 10-13 are included in the rejection.
At claims 1, 8, 15, 17 and 25, the multiple use of the term “about” in the definition of ranges causes a lack of clarity. Dependent claims 2-7, 9-14, 16, 18-21 and 26-30 are included as they do not obviate the rejection.
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.
Claims 1-32 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims recite are broadly drawn to a genus of method claims for preserving a genus of pollen from a genus of dicotyledonous plants comprising collecting fresh pollen and introducing the pollen to field conditioning conditions including a relative humidity ranging from about 50% to about 100% (or 0% to 99%) , a temperature from about-10°C to about 10oC, and air pressure from about 15 kPa to about 150 kPa; wherein the pollen is dehydrated to achieve a pollen moisture content of about 15% to about 35%, about 40% to 58%, the temperature and relative humidity are adjustable and maintain moisture content at about 40% to about 58%, or at about 50% to about 57%; the field conditioning conditions include a flow of one or more continuously refreshed selected gases; said method the fresh pollen is collected from actively shedding plant anthers by crushing, grinding or disrupting the anther to obtain the pollen therefrom; said method wherein the dehydration of the pollen is conducted by heat drying, by a saturated salt solution, silica drying, sun drying, microwave drying, vacuum drying or combination of controlled humidity and ventilation; said method wherein the relative humidity level is controlled by using a saturated salt solution; two-pressure process; two-temperature process, or by using one or more of a dew-point generator, an atomizer, a mixed-flow generator or by a sonicator; said method wherein the field conditioning conditions include continuous, adjustable, positive or negative air flow that is provided such that the air can be exchanged at a rate of 1 or more times per hour. The claims are also drawn to a method of preserving pollen from dicotyledonous plants by subjecting freshly collected pollen and/or anthers to preservation conditions including an air flow at a humidity ranging from about 0% to about 99%, at air pressure from about 15kPa to about 150 kPa, and a temperature from about -10°C to about 10oC, and; the selected gas is nitrogen gas with a concentration of about 78% to 100%; said method wherein the step of storing the pollen and/or anthers comprises a temperature ranging from -80oC to -30oC, -30oC to -10oC, or -10oC to 10oC.
In contrast, the specification describes a method of conditioning maize pollen using the specific controlled environmental factors including relative humidity, temperature, air pressure levels, and gaseous components of the atmosphere, to maintain specific pollen moisture content . The specification also describes the effect on maize pollen moisture content of storing freshly collected pollen for days at different pressure and humidity levels, and show the pollen germination rate of different genotypes of maize after the treatment. Results show that 3 out of the six genotypes of maize pollen tested have reduced viability as pressure was reduced. Also, the germination rate varied between the genotypes within the same species of maize. Figures 9 and 10 show pollen moisture varied six days after storage at about 15 kPa. Therefore, Applicant’s own specification shows that the effects of the treatment is strongly dependent on the genotype. These are genus claims.
The purpose of written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. For broad generic claims, the specification must provide adequate written description to identify the genus of the claim.
“The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice….reduction to drawings…., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus”. MPEP 2163.
Furthermore, a “representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is a substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure ‘indicates that the patentee has invented species sufficient to constitute the genus”. ‘ A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when…..the evidence indicates ordinary artisan could not predict the operability in the invention of any species other than the one disclosed.’ In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1247, 1282 (Fed. Cir. 2004)”. MPEP 2163.
The instant specification fails to describe a single method that employs with a single species of dicotyledonous pollen with the field conditioning conditions as recited in the claims to achieve and maintain pollen moisture content of about 40% to about 58%, or about 50% to about 57%. The specification also fails to describe the specific physiological, genotypic or morphological characteristics common to the genus of pollen from dicots that can be preserved using the claimed methods. There is no evidence in the specification that shows the field conditioning method disclosed for maize pollen is also applicable to the preservation of pollen from any and all dicotyledonous plants. The dicotyledonous plants include an extremely large number of plant species having pollens with different physiological and genetic characteristics, which are neither exemplified in the instant specification nor are described in the prior art. The claims are so broad in that it require field conditioning conditions including a wide range of temperature, relative humidity and air pressure, to achieve pollen moisture content of about 40% to about 58%, or to about 50% to about 57% in a diverse genotypes of all dicots. However, these conditions were tested for maize pollen only. In addition, it is known to one of skill in the art that pollens from different plant species differ in moisture content, viability and germination rate under different environmental conditions such as temperature, relative humidity, atmospheric pressure, etc. For example, the state of the prior art as evidenced by Fonseca et al ((2005); Applicant’s IDS) is that most studies on pollen preservation and storage are limited to maize pollen.
Paragraph [0094] of the specification states that many factors including genetic background can affect the viability of pollen and Table 1 clearly shows that the effect seen is genotype dependent. The specification also determines that it is equally important to consider the interaction between the pollen genotype and physical parameters (temperature, relative humidity, and air pressure). Therefore, the characteristics of pollen obtained by the claimed method are expected to vary widely. In addition, the prior art provides limited studies on effects of the combination of temperature, relative humidity, and air pressure on the preservation and storage of pollen from the various genotypes of dicot plant species. It is unpredictable that the requirements established for maize pollen preservation and storage would be applicable to all genotypes of pollen from dicotyledonous plant. Applicant’s own working examples show that even genotypes from the same plant species (maize) respond differently to the same treatments. Consequently, the instant specification fails to provide evidence that shows Applicant’s possession of the claimed genus of methods requiring the field conditioning of pollen grains of various genotypes from a large number of dicot plants, subjected to a wide range of temperatures, relative humidity, vacuum treatments, dehydration, positive/negative air flow, gases displacing oxygen, and pressures conditions as listed in the claims to achieve and maintain the pollen moisture content about 40% to about 58%, or about 50% to about 57%.
The University of Rochester v. G.D. Searle & Co., Inc.(, U.S. District Court, Western District of New York, Decision and Order No. 00-CV-6161L,) decided 05 March 2003, at page 8, bottom paragraph, that method claims are properly subjected to a written description requirement if the starting material which requires that method is itself inadequately described. The court specifically stated, "(T)he claimed method depends upon finding a compound that selectively inhibits PGHS-2 activity. Without such a compound, it is impossible to practice the claimed method of treatment. It means little to “invent” a method if one does not have possession of a substance that is essential to practicing that method. Without that substance, the claimed invention is more theoretical than real;……… and there is no meaningful possession of the method."
Therefore, given that the broad scope of the claims encompassing pollen from a multitude of dicot plant species having pollen of different physiological and genotypic characteristics, given that the prior art provides limited studies regarding dicot pollen preservation and storage, and given that the specification fails to describe a single method that employs with pollen from a single dicot plant, the claimed invention lacks adequate written description.
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, 3, 8, 10, 15, 19, 25 and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,844, 347. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the application and the issued patent recite a step of subjecting fresh pollen from s dicotyledonous flower to field conditioning conditions including relative humidity ranging from about 50% to about 100%; temperature ranging from about -10° C. to about 10° C.; and air pressure ranging from about 15 kPa to about 150 kPa; resulting in field conditioned pollen having a pollen moisture content of about 40% to about 58%.
The claims of the instant application are drawn to method of preserving pollen from a dicotyledonous plant comprising collecting fresh pollen and subjecting the pollen to field conditioning conditions including a relative humidity ranging from about 50% to about 100%, a temperature from about-10°C to about 10oC, and air pressure from about 15 kPa to about 150 kPa; wherein the pollen is dehydrated to achieve a pollen moisture content of about 40% to 58%, the temperature and relative humidity are adjustable and maintain moisture content at about 40% to about 58%, or to about 50% to about 57%. Claim 4 of the issued patent recites the step of collecting fresh pollen from soybean, canola and sorghum; subjecting the pollen to field conditioning conditions including a relative humidity ranging from about 50% to about 100%, a temperature from about-10°C to about 10oC, and air pressure from about 15 kPa to about 150 kPa; wherein the pollen is dehydrated to achieve a pollen moisture content of about 40% to 58%, the temperature and relative humidity are adjustable and maintain moisture content at about 40% to about 58%, or to about 50% to about 57%. Given that the claims of instant application require pollen from any dicotyledonous plant and the claims of the issued patent require specific dicotyledonous plant (soybean, canola or sunflower), the claims of the instant application are genus encompassing the specific species recited in the issued patent. In addition, the method of producing field conditioned pollen from a dicotyledonous plant of the instant application, and the method of using field conditioned pollen from a dicotyledonous plant in plant breeding of the issued patent claim, are obvious over each other, absent evidence to the contrary.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Connor et al (Euphytica (1993) 68:77-84) teach variability expected in hydration/dehydration responses to achieve an equilibrium moisture content (EMC) of pollen from diverse plant species including pear, apple and citrus. According to Connor et al, “pollens which remain viable after drying to low moisture contents are termed desiccation-tolerant, whereas pollens that lose viability during drying to relatively low moisture contents are termed desiccation-sensitive.
Sato et al. (Euphytica (1998)103:29-33) teach the importance of preserving pollen before storage to maintain viability/fertility. Sato et al pretreatment of pollen to be preserved comprising collecting fresh pollen grains from anthers of Brassica rapa , and dehydrating it under relative humidity of 15% at 20C for 24 hours in the dark; they were then preserved; placing the pretreated pollen in chambers with relative humidity between 15% and 66% and temperature ranging from -20 to 250C; effects of relative humidity and temperature on pollen viability or germination rates were assessed during preservation. Sato et al, however, do not teach pollen moisture content.
Iovane et al (Agronomy (2022) teach the combined effect of temperature and humidity on viability of pollen from 12 olive cultivars. Iovana et al do not teach pollen moisture content.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/Primary Examiner, Art Unit 1662