DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group III, claims 21-34, in the reply filed on 10/14/25 is acknowledged.
Claims 1, 10, 12, 13, 17 and 40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 112-2nd paragraph
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 21-34 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 21 is vague and indefinite for use of the term “inactivated A. baumannii immunogen” because the method produces an “inactivated A. baumanii” and not an individual “immunogen”. The claimed process describes the production of a whole cell vaccine, and not an "immunogen" that was "obtained " from a bacterium. “Immunogen" is thus indistinguishable from the strain as such. Applicants should remove the term “immunogen” from the claim if a whole cell vaccine is intended. If that is not intended then the claim is incomplete for lacking method steps as there is no isolation of any “immunogen.” However, it is noted that the instant specification only provides for whole cell vaccines. Appropriate clarification and/or correction is required.
Claim 22 is vague and indefinite and it appears this culture step belongs in the method of claim 21 in order to provide a complete method. The phrase “cultured A. baumannii” is also vague and indefinite. It is unclear how the “cultured A. baumannii” is different as there are no particular culture steps or ingredients. The use of the “to obtain cultured A. baumannii” appears to be redundant. Appropriate clarification and/or correction is required.
Claims 24 and 25 are vague and indefinite for the use of the phrase “planktonic growth conditions” and “biofilm growth conditions”, respectively, because it is unclear what conditions are intended by these descriptions and they appear to be critical to the method. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claims 27, 28, 32 are vague and indefinite due to the broad description of “a peptide.” The metes and bounds of this cannot be understood. The peptide may be from any source, any size, any properties and represents an enormous amount of variability and it is unclear which peptides may function in the method as claimed. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Claim 27 is also vague and indefinite because it is unclear what a “complex thereof” means, e.g., there is a culture, a divalent cation peptide and a buffer already, so what is “or a complex thereof”? Appropriate clarification and/or correction is required.
Claim 34 is vague and confusing because the phrase “at least partially replacing air in contact with the A.baumanii with a non-reactive gas” is vague and indefinite. It is unclear how this is to happen as the claim allows for the A.baumanii to be in an “open air” environment such as a petri dish or broth culture. There is no “closed container” which would allow for this to happen and the use of “non-reactive gas” is vague and it is a critical limitation. Additionally, the use of multiple “and/or” s makes the claim unclear. It is also unclear how one “partially replaces air in contact with the A. baumannii”. What constitutes “partially” and how is this accomplished? The “and/or” does nor require any container or necessarily the ‘gas”. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 112- Written Description
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 21-34 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.
The instant claims recite a method or producing an “inactivated A. baumannii immunogen”; however, the process by which the immunogen was obtained is not specified and the process it depends from only broadly describes a method of exposing A. baumannii bacteria to either ionizing radiation and ultraviolet radiation; exposing solely to ionizing radiation; or exposing solely to ultraviolet radiation. There is written description for producing an inactivated A. baumannii (whole cell bacterium), but not an individual immunogen. The broad term "immunogen" is not particularly defined in terms of its type or structure, e.g., unsupported types of immunogens isolated protein- and polysaccharide immunogens are encompassed. The terms "obtain/derive" are product-by-process-type terms. It makes perfect sense to "obtain/derive" an isolated immunogen from a bacterium., but there are no concrete structural features recited. Moreover, irradiation kills A. baumannii by DNA-damage/mutations. A priori, the fact that such cells are killed by DNA-damage in one gene, does not mean that the isolated immunogenic protein comprises any such mutation. Indeed, applicants have only provided whole-cell vaccines. The technical information for making and screening protein- or polysaccharide-immunogens for the desired "inactivity" is simply not present in the specification (GL F-IIl, 1) nor available from common general knowledge, specifically not for all the vague conceivable activities.
The claims only recite producing an inactivated A. baumannii and not an isolated A. baummanii immunogen. Written support is only provided for the whole cell A. baumannii that is inactivated "by irradiation". Neither the type of molecule, nor type of activity that is inactivated is defined, nor the type of structural change that leads to the lack of activity. This is thus effectively a desideratum based on a vague functional description. E.g. a given bacterial protein /from the irradiated bacterium) may have retained some form of activity (i.e. falls outside the claimed scope) but may have lost a different type of activity (which falls inside the claimed scope). Depending on which assay is performed the claim-scope thus changes as does the claimed immunogen. Moreover, to find all conceivable immunogens from irradiated A.baumannii, the skilled person would have to inter alia screen (ia) all conceivable mutants of all A. baumanni proteins, or (ib) all radiation-damaged structures from all organic molecules/polysaccharides/etc. from A. baumanni and then (ii) screen them for all conceivable activities that they might have lost. This is clearly an entire research project undue burden. This is exacerbated by the fact, that radiation-damage is effectively random, so that repeating successful isolation of (e.g. protein- or polysaccharide) immunogens relies exclusively on an element of chance. This is also unduly burdensome.
The claimed genera of any “immunogen” from an A. baumannii bacteria has widely variable structures and associated functions. The claimed process method produces an irradiated A. baumannii whole cell, but does not speak to any isolated antigens/immunogens thereof. A very broadly claimed method is recited in the claims and different steps and processes are included which would change any resultant immunogens. Claim 21 allow for either ionizing radiation and ultraviolet radiation in “any” amount ‘sufficient to inactivate A. baumannii bacteria; or just ultraviolet radiation; or just ionizing radiation. No more specifics are provided and this is insufficient to adequately define and identify any resultant immunogen in claim 41. Further, any variations in the method could produce vastly different immunogens, e.g., a minor change in structure may result in changes affecting function, since, the specification provided no additional information (species/variant/mutant) correlating structure with function, one skilled in the art cannot reasonably conclude that applicant had possession of the claimed invention at the time the instant application was filed. Furthermore, "Possession may not be shown by merely describing how to obtain possession of members of the claimed ,genus or how to identify their common structural features" (See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895). A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the .gene does (function), rather what it is (structure), see University of California v. Eli Lilly & Co., 43 USPQ2d 1938, thus above claims lack adequate written description.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of claimed nucleotides such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed.
The purpose of the "written description" requirement is broader than tomerely explain how to "make and use"; the applicant must convey with reasonableclarity to those skilled in the art that, as of the filing date sought, he or she was inpossession of the invention. The invention is, for purposes of the "writtendescription" inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar,935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).Furthermore, the written description provision of 35 USC § 112 is severable fromits enablement provision; and adequate written description requires more than amere statement that it is part of the invention and reference to a potential methodfor isolating it. The nucleic acid itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, paragraph 1, "'Written Description" Requirement (66 FR 1099-1111, January 5,2001) state, "[p]ossession may be shown in a variety of ways including description of an actualreduction to practice, or by showing the invention was 'ready for patenting' such asby disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention" (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. The Guidelines further state, "[f]or inventions in an unpredictable art, adequatewritten description of a genus which embraces widely variant species cannot beachieved by disclosing only one species within the genus'" (Id. at 1106);accordingly, it follows that an adequate written description of a genus cannot beachieved in the absence of a disclosure of at least one species within the genus.
The scope of the claim includes numerous structural variants, and the genus is highly variant because a significant number of completely different antigens/immunogens is permitted. The specification does not describe any members of the claimed genus by complete structure. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus of immunogens. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described. There are no drawings or structural formulas disclosed of any of theseimmunogens. Based on the lack of knowledge and predictability in the art, those of ordinary skill in the art would not conclude that the applicant was in possession of theclaimed Genus.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov
Claim Rejections - 35 USC § 102
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.
Claim(s) 21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McConnell et al (US 2017/0065700; as provided by Applicants).
The instant claims describe a generic method of irradiating A. baumanni whole cells to attenuate them. Independent Claim 21 allows for a method of exposing A. baumannii bacteria to either ionizing radiation and ultraviolet radiation; exposing solely to ionizing radiation; or exposing solely to ultraviolet radiation. The instant claims only describe making an irradiated whole cell A. baumannii, not an isolated A. baumannii “immunogen”. The process is not limited to any particular dose and cover products with an entire gamut of vague random mutations at random positions. The prior art is applied accordingly.
McConnell discloses A. baumannii immunogen (para [0055]; “In another preferred embodiment of the invention, the cell or strain of the invention is preferably an A. baumannii cell, particularly an attenuated A. baumannii cell.” Paragraph [0051] recites: “It is understood that “inactivated cell" in the present invention is a cell that does not have the ability to replicate but that conserves its immunogenic capacity”), wherein the immunogen is obtained and/or derived from irradiation-inactivated A. baumannii bacteria and/or wherein the immunogen is irradiation-inactivated (para [0051]; The inactivation of the cells of the invention can be performed using diverse methods known in the state of the art for example, although not limited to, ultraviolet light, ionizing radiation"). McConnell further discloses that the A. baumannii immunogen is obtained and/or derived from irradiation-inactivated A. baumannii (para [0051]) grown under conditions such that one or more different bacterial immunogens that stimulate protective immunity are present (para [0051)). McConnell further discloses that the immunogen has been inactivated using ionizing radiation (para [0051]; “ionizing radiation’). McConnell teaches immunogenic composition comprising an attenuated strain of A. baumannii (para [0055]; “preferably an A. baumannii cell, particularly an attenuated A. baumannii cell"); expressing an antigenic epitope-containing bacterial protein (para (0051); "It is understood that “inactivated cell" in the present invention is a cell that does not have the ability to replicate but that conserves its immunogenic capacity"; para [0042]; "By eliminating the LPS component according to the method as detailed in aspect F above, we focus the antibody raising to antibodies against less variable epitopes of the bacterial surface, not related to the LPS component. These epitopes are conserved among A. baumannii strains or individual isolates belonging to all A. baumannii international clones used in A. baumannii classification") wherein bacterial infectivity of the A. baumannii has been decreased or abolished (para [0051]) by ionizing radiation and/or UV radiation (para [0051)).
Claim Rejections - 35 USC § 103
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.
Claim(s) 22-26, 33 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over McConnell et al (US 2017/0065700; as provided by Applicants) in view of Gentile et al (Pathogens, vol. 3, no. 3, 18 August 2014 (2014-08-18), pages 704-719; provided by Applicants) and Nairn et al (Cell Host & Microbe, vol. 19, no. 6, June 2016; pages 826-836; provided by Applicants).
The teachings of McConnell, as set forth above, discloses A. baumannii immunogen (para [0055]; “In another preferred embodiment of the invention, the cell or strain of the invention is preferably an A. baumannii cell, particularly an attenuated A. baumannii cell.” Paragraph [0051] recites: “It is understood that “inactivated cell" in the present invention is a cell that does not have the ability to replicate but that conserves its immunogenic capacity”), wherein the immunogen is obtained and/or derived from irradiation-inactivated A. baumannii bacteria and/or wherein the immunogen is irradiation-inactivated (para [0051]; The inactivation of the cells of the invention can be performed using diverse methods known in the state of the art for example, although not limited to, ultraviolet light, ionizing radiation"). McConnell further discloses that the A. baumannii immunogen is obtained and/or derived from irradiation-inactivated A. baumannii (para [0051]) grown under conditions such that one or more different bacterial immunogens that stimulate protective immunity are present (para [0051)). McConnell further discloses that the immunogen has been inactivated using ionizing radiation (para [0051]; “ionizing radiation’). McConnell teaches immunogenic composition comprising an attenuated strain of A. baumannii (para [0055]; “preferably an A. baumannii cell, particularly an attenuated A. baumannii cell"); expressing an antigenic epitope-containing bacterial protein (para (0051); "It is understood that “inactivated cell" in the present invention is a cell that does not have the ability to replicate but that conserves its immunogenic capacity"; para [0042]; "By eliminating the LPS component according to the method as detailed in aspect F above, we focus the antibody raising to antibodies against less variable epitopes of the bacterial surface, not related to the LPS component. These epitopes are conserved among A. baumannii strains or individual isolates belonging to all A. baumannii international clones used in A. baumannii classification") wherein bacterial infectivity of the A. baumannii has been decreased or abolished (para [0051]) by ionizing radiation and/or UV radiation (para [0051)).
Instant claims 22-24, recite that the A. baumannii is cultured prior to irradiation and that culture prior to plating/irradiation cells were grown under vague planktonic or biofilm conditions. Since no particular growth conditions are specified (medium, oxygen, temperature, etc.) no particular expression profile follows. These seem to be routine growth-conditions for A. baumanni, as shown Nairn (planktonic and zinc starvation) and Gentile (describes biofilm growth conditions for A. baumannii), and thus obvious way of providing a source-material for irradiation. Also, no particular effect is attributed to these growth-conditions in the present specification, neither in terms of vaccine-efficacy nor in terms of degree of inactivation. Since the claims provide no actual description of these conditions, they are obvious over what is taught as “routine” by the prior art. With respect to instant claim 26, in that the UV is applied for 5 minutes at 3 mW/cm3. No material of the vessel is defined, no volume or cell-number of the bacteria-culture is defined. Hence, a particular dose-per-cell does not follow. A particular DNA-damage load per cell then also does not follow. In absence of a particular technical effect this amounts to routine process optimization of one of multiple interplaying parameters. Additionally, no benefits of combining ionizing and UV radiation are ever discussed in the specification either. Indeed, since intensity/dose of radiation is not defined, no particular damage patterns (number/distribution of DNA-damages) is credible over the whole scope. Adding e.g. insignificant amounts of ionizing radiation is then not inventive. Since McConnell recites both UV radiation and ionizing radiation, it would have been obvious to combine in any manner or solely use one or the other. With respect to instant claim 34, the wording of the claim is very confusing and as written there is no requirement for either a non-reactive gas or necessarily a container. The teachings of the prior art meet the vague requirements of the claim.
Claim(s) 27-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over McConnell et al (US 2017/0065700; as provided by Applicants) in view of Daley et a (US 2016/222343; provided by Applicants).
The teachings of McConnell are set forth above. Although McConnell discloses the antigenic epitope- containing bacterial protein (para [0051], [0042]), McConnell does not particularly disclose a culture method which includes exposing the A. baumannii or cultured A. baumanii to a divalent cation peptide and a buffer (instant claims 27-31).
However, Daly discloses the antigenic epitope containing bacterial protein is protected from damage using a chemical complex comprising a manganous ion (Mn2+), a peptide, and a buffer (para (0004); “The invention provides methods of producing vaccines directed against microorganisms, with the methods comprising culturing, harvesting and/or suspending the microorganism in the presence of a radiation-protective composition and irradiating the microorganism with a dose of radiation sufficient to render the microorganism replication-deficient. The radiation-protective compositions used in the methods of the present invention comprise at least one decapeptide in a mixture of manganese-phosphate or manganese-bicarbonate buffer. The invention also provides methods of rendering a bacterium in culture resistant to ionizing radiation (IR), with these methods comprising culturing the bacteria in the presence of a radiation- protective composition"). SEQ ID NO: 1 of Daly is: Asp Glu His Gly Thr Ala Val Met Leu Lys, e.g., the same as SEQ ID NO: 1 of claim 30. One of ordinary skill in the art would have known how to use and include the protective composition described by Daly as a means of protecting the antigenic epitope- containing bacterial protein of McConnell from radiation damage during preparation, without undue difficulty. Consequently, it would have been obvious for one of ordinary skill in the art to combine an antigenic epitope- containing bacterial protein, as disclosed by McConnell, with the antigenic epitope containing bacterial protein is protected from damage using a chemical complex comprising a manganous ion (Mn2+), a peptide, and a buffer, as disclosed by Daly, because it would have prevented the antigenic epitope from being damaged during the irradiation step of the preparation. Instant claim 32 further specifies (i) 0.5-10 mM of MnCl2, (ii) 0.5 - 10 mM of the still vague peptide and (iii) 5-500 mM of phosphate. Due to vagueness, the effect of (ii) is still not apparent, this addition thus still deemed arbitrary. MnCl2 in this range seems to be one among a list of routine supplements for A. baumanni media (see e.g. in light of Gentile and Nairn). Since the Mn, phosphate, decapeptide are supposed to protect the protein-epitopes form damage it would have been obvious that they are contacted with the whole cell during irradiation. One of ordinary skill in the art would have recognized that an irradiation-inactivated bacterial vaccine is generally considered safer than an unattenuated vaccine, and therefore would have used the methods set forth above to generate an irradiation-inactivated A. baumannii immunogen. Facing the technical problem of providing an alternative method of producing an attenuated A. baumanni whole cell vaccine, the skilled person would have had a reasonable expectation of success that applying routine culturing + routine irradiation would ultimately lead to an attenuated A. baumanni strain.
Pertinent art not presently relied upon:
Dollery et al (Vaccines. January 2021. 9(2): ; provided by Applicants- published after Applicants effective priority date of 12/22/20)
Spellberg et al (US 2012/301474; provided by Applicants) teaches A.baumanii protein vaccines. The only mentioned feature in the product by process claim 40 does not limit the nature/structure of the ultimately isolated immunogen. A known product/protein is not rendered novel merely by being produced by a new method.
Nitzan et al (Current Microbio. June 2001. 42(6): 408-414) discloses photo-inactivation of A. baumannii.
Seo, H. (Clin. Exper. Vaccine Research. July 2015. 4(2): 145-158; provided by Applicants) is a review article that irradiation for vaccine development is broadly applicable to a large and varied host of different pathogens/cells/viruses.
Dubensky et al (Current Opinion in Biotech. December 2012. 23(6): 917-923; provided by Applicants) and Pace et al (Vaccine. October 1998. 16(16): 1563-1574; provided by Applicants) are review articles which teach using gamma-irradiation (Dubensky) and UV-inactivation (Pace) to obtain attenuated bacteria is common knowledge in the art.
Kadke 2019; XPO36786047 discloses A. baumannii growth in TSB under planktonic conditions.
Ainsworth et al (2017; Vaccine. 35(26): 3387-3394; provided by Applicants). discloses UV-inactivated A. baumanni as such (chapter 2.4 and 2.5; and abstract). This is used as analyte. The context as a whole is vaccination with live attenuated strains (see title). Inactivated whole cells of A. baumanni as vaccine candidates seem to be state of the art (page 3388, left column, lines 6-19). It does not specify how long UV was applied.
The concept of using irradiation to damage DNA, specifically gene involved in virulence/growth-rate, and thereby reduce DNA-damage has been done for countless bacteria, and then it seems obvious that the same should also be feasible for A. baumanni. All organisms and thus all bacteria have some growth-critical genes, after all.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Thursday from 8:00 AM-6:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gary Nickol, can be reached on (571) 272-0835.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/ Primary Examiner, Art Unit 1645 10/27/25