To:
`
`Subject:
`
`Sent:
`Sent As:
`
`PHILIP R. ZENDER(ip-squiretm@squirepb.com)
`U.S. Trademark Application Serial No. 86854469 - GENE PILL -
`120753.00107
`January 11, 2024 02:06:28 PM EST
`tmng.notices@uspto.gov
`
`Attachments
`
`screencapture-www-wsj-com-articles-SB111930907838864576-17048965208011
`screencapture-www-medscape-com-viewarticle-538709-17048966542801
`screencapture-www-medscape-com-viewarticle-538709-17048966921351
`screencapture-www-cell-com-trends-genetics-fulltext-S0168-9525-01-02390-3-
`17048969619071
`screencapture-www-genome-gov-genetics-glossary-Gene-Therapy-17048974997361
`screencapture-www-vcuhealth-org-news-fda-approved-treatments-use-gene-therapy-to-help-
`patients-with-sickle-cell-disease-17048979383151
`screencapture-www-euronews-com-next-2022-09-28-how-gene-therapy-with-a-switch-could-
`revolutionise-the-treatment-of-diabetes-and-obesity-17048982872811
`screencapture-www-pfizer-com-science-innovation-gene-therapy-genes-as-medicines-
`17048984343481
`screencapture-engene-com-17048993527121
`screencapture-webcache-googleusercontent-com-search-17048994452401
`screencapture-www-genengnews-com-news-takeda-engene-collaborate-on-gene-pill-
`17048998938491
`screencapture-www-fiercebiotech-com-r-d-biotech-upstart-engene-preps-first-trial-for-next-
`gen-gene-pill-tech-17049002483851
`
`United States Patent and Trademark Office (USPTO)
`Office Action (Official Letter) About Applicant’s Trademark Application
`
`U.S. Application Serial No.  86854469
`
`Mark:   GENE PILL
`
`Correspondence Address:  
`PHILIP R. ZENDER
`SQUIRE PATTON BOGGS (US) LLP
`555 CALIFORNIA STREET, SUITE 550
`SAN FRANCISCO CA 94104
`UNITED STATES
`
`Applicant:   Engene Inc.
`
`Reference/Docket No.  120753.00107
`
`Correspondence Email Address:   ip-squiretm@squirepb.com
`
`
`
`
`

`

`REQUEST FOR RECONSIDERATION AFTER FINAL ACTION DENIED
`
`
`
`Issue date:   January 11, 2024
`
`Applicant’s request for reconsideration is denied.   See 37 C.F.R. §2.63(b)(3).  The trademark
`examining attorney has carefully reviewed applicant’s request and determined the request did not:  (1)
`raise a new issue, (2) resolve all the outstanding issue(s), (3) provide any new or compelling evidence
`with regard to the outstanding issue(s), or (4) present analysis and arguments that were persuasive or
`shed new light on the outstanding issue(s).  TMEP §§715.03(a)(ii)(B), 715.04(a).  
`
`Accordingly, the following requirement(s) and/or refusal(s) made final in the Office action dated May
`2, 2023 are maintained and continued: Section 2(e)(1) Refusal - Class 42.  
`
`See TMEP §§715.03(a)(ii)(B), 715.04(a).  
`
`In addition, the following requirement(s) and/or refusal(s) made final in that Office action are
`withdrawn:  Section 2(e)(1) Refusal - Class 45.
`See TMEP §§715.03(a)(ii)(B), 715.04(a).
`
`Section 2(e)(1) Refusal
`
`The Section 2(e)(1) Refusal is continued for Class 42 only.  
`
`As indicated previously, applicant’s services include pharmaceutical research and product development
`services.  This encompasses pharmaceutical research and development of pills that feature genes or
`genetic materials for gene therapy purposes.  The Fiercebiotech article notes that applicant plans to use
`its gene therapy technology “to develop a gene pill that can offer an oral approach to developing a long-
`acting insulin.”  The Genengnews article notes that applicant has been developing “gene pill delivery
`systems” that “could be used to treat a range of immune disorders.”  Thus, applicant’s pharmaceutical
`research and development appears to be actively focused on gene pills.  The evidence supports that the
`term is also widely used in applicant’s industry.  The Medscape article cites a Wall Street Journal report
`informing of “a new technology now under development, aiming to deliver injectable protein drugs
`using an oral "gene pill" approach.”  The article indicates, “Inspired by gene therapy, it is called a
`"gene pill" and contains the gene for a disease-treating protein rather than the protein itself.”  The
`Science Daily report informs of approaches to “make gene therapy treatments that are stable enough to
`take as a pill.”  The UCSF article informs that “the oral delivery of normal genes has been a long-
`sought and elusive technique,” and is “sometimes referred to as a “gene pill”.”  The Science.org article
`titled “A Gene Pill for Lactose Intolerance?” notes of new techniques allowing for people to “one day
`be able to pop a “gene pill” that offers long-lasting treatment” for particular ailments.   In the Euronews
`article, the gene therapy company MeiraGTx CEO indicates that they “can now put the genes…that
`control metabolism into the body and give a pill when we want those drugs.”   The VCU Health articles
`informs of gene therapies with a goal of developing a pill for the treatment.  Based on the evidence
`from the NIH, gene therapy refers to “a technique that uses a gene(s) to treat, prevent or cure a disease
`or medical disorder.”   Applicant’s pharmaceutical research and development services could feature
`pills that use genes to treat disorders, in other words, a gene pill.  Thus, the wording immediately
`conveys information about the services. 
`
`Applicant’s argument that “pill” has other meanings in this context is not persuasive. Determining the
`
`

`

`descriptiveness of a mark is done in relation to an applicant’s goods and/or services, the context in
`which the mark is being used, and the possible significance the mark would have to the average
`purchaser because of the manner of its use or intended use. See In re The Chamber of Commerce of the
`U.S., 675 F.3d 1297, 1300, 102 USPQ2d 1217, 1219 (Fed. Cir. 2012) (citing In re Bayer
`Aktiengesellschaft, 488 F.3d 960, 963-64, 82 USPQ2d 1828, 1831 (Fed. Cir. 2007)); TMEP
`§1209.01(b). Descriptiveness of a mark is not considered in the abstract. In re Bayer Aktiengesellschaft,
`488 F.3d at 963-64, 82 USPQ2d at 1831. Additionally, as noted previously, applicant has indicated that
`it "anticipates that its research and development services will encompass pills or pill shaped forms as a
`delivery method for its therapeutics," its "product development services will encompass pills or pill
`shaped forms as a delivery method for its therapeutics," and "its product development services, which
`may be licensed, will encompass pills or pill shaped forms as a delivery method for its therapeutics." 
`Thus, applicant’s own statements support the descriptiveness of “pill” in the context of applicant’s
`services.
`
`Partial Abandonment
`
`If applicant does not respond to this Office action by the response deadline, International Class(es) 42
`will be deleted from the application.  The application will then proceed with International Class(es) 45
`only.  See 37 C.F.R. §2.65(a)-(a)(1); TMEP §718.02(a).
`
`If applicant has already filed an appeal with the Trademark Trial and Appeal Board, the Board will
`be notified to resume the appeal.   See TMEP §715.04(a).  
`
`If applicant has not filed an appeal and time remains in the response period for the final Office
`action, applicant has the remainder of that time to (1) file another request for reconsideration that
`complies with and/or overcomes any outstanding final requirement(s) and/or refusal(s), and/or (2) file a
`notice of appeal to the Board.  TMEP §715.03(a)(ii)(B).
`
`
`/Tejbir Singh/
`Tejbir Singh
`Examining Attorney
`LO106--LAW OFFICE 106
`(571) 272-5878
`Tejbir.Singh@USPTO.GOV
`
`
`
`

`

`Q
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`MarketWatch
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`DJIA Futures 37752.00
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`11=)3)
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`el me Yea)
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`MARKETS NEWSLETTER |
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`English Edition ¥ Print Edition|Video|Audio|Latest Headlines|More ¥
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`& elastic
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`Generative Al is already changing the
`landscape of public sector-
`
`hd
`
`‘GenePill' Offers Alternative to Shots
`
`By SharonBegleyStafReporter ofTHE WALL STREETJOURNAL
`June21, 200512:01 am ET
`© Giftunlocked article
`en mA
`Forpeople whohaveto inject themselves regularly withinsulinto treat diabetes,
`UMLVersILy SCLEMLUSLS ANG a DLOLECILNOLOZY COllpany dare QeVelOpLNg all allernauve
`erythropoietin to treat anemia orotherprotein drugs for various diseases, there
`to injecting the drugs. Inspired by genetherapy,it is called a "genepill” and
`ReeMESS
`
`contains the gene for a disease-treating protein ratherthanthe proteinitself. claim your share
`
`hi Ae)8 lg
`business accepted
`Visa/Masterca rd
`botwoon 2004-20190,
`you a=) elig | ble to
`
`Be
`
`

`

`WWlally NEIPIUL Grugs are aClLually PrOLlells. GUL PrOLells MaKe POOF Pills, VECAUSeE
`they are broken downin the gutor poorly absorbed,withthe result that they
`don't deliver the intended benefit. The only choiceis to inject them.
`
`However, the bodyitself makesproteins all the timein cells, following the
`instructions ofgenesinthe cells. Now researchers are working ondelivering
`genes for medicinalproteins to the body througha pill. A study in lab animals
`showedthat, not only do the genessurvive their digestivetrip intact, they also
`get incorporatedinto cells of the gut -- which then producethe helpful proteins
`for the body to use.
`
`Althoughtheresearchis preliminary, with studies in humansstill on the
`drawing boards, outside experts agree it shows promise. The genepill "could
`provide an effective alternative method for delivering protein drugs currently
`administered only through injection,” said David Klonoff,clinical professor at
`the University of California, San Francisco, andeditor in chiefofthe journal
`Diabetes Technology & Therapeutics, which published the studyin its June
`issue.
`
`kedav's protein drues. such as erowth hormone to treat dwarfism and blood
`
`Today's protein drugs, such as growth hormoneto treat dwarfism and blood
`factors to treat hemophilia, have several drawbacks. Patients often skip doses
`because the drugs haveto be injected, rather than swallowed,Also, these
`proteins are either extracted from humancadavers or animaltissue, whichis
`slow andinefficient, or -- more common-- produced through recombinant DNA,
`whichis expensive. Moreover,injectable drugs are difficult and expensive to
`store, limiting their use in developing countries.
`
`The genepill is designed to avoid these problems. Thecells lining the intestine
`are the only ones that take up the DNAforthe therapeutic protein, which the
`cells release into the bloodstream.
`
`The geneitself stays out of the bloodstream, with the result that it can’t reach
`tissues whereit might posearisk. In sometrials of traditional gene therapy,in
`whicha virus ferries a therapeutic geneinto a patient’scells, the virus has
`caused dangerous inflammation or disrupted cancer-suppressing genes, causing
`two deaths and leading the Food and Drug Administration to suspend some
`
`settleme
`
`between 2004-2019,
`you're eligible to
`claim your share
`of a $5.5 billion
`
`

`

`gene-therapytrials in the U.S.
`
`Becausecells of the intestine are sloughedoff, excreted and replaced every few
`days, there is little danger thatthe inserted genewill go astray or deliver too
`higha doseof the therapeutic protein, says Stephen Rothman, professor
`emeritus at UCSF and a developerof the genepill. The pill would be taken every
`two daysorso,
`
`In 1997, Dr. Rothmanandthree UC colleagues founded Genteric Inc., ofAlameda,
`Calif., whichis developing the genepill commercially. UCSF holds four patents
`onthe genepill, for whichit has granted an exclusivelicense to Genteric. Dr.
`Rothmanhasa financial stake in the closely held company.
`
`In the newstudy, he andhis colleagues gave lab rats and miceseveraldifferent
`genes, througha tube. They foundthat the intestine cells do take up the gene and
`makethe protein, and that they secrete the proteininto the blood, Whenthey
`used the gene for insulin, they showedthat the insulin not only gets into the
`blood but also produces a therapeutic response, in this case lowering levels of
`blood sugarin rats with diabetes.
`
`"Our approachseeks to avoid manyof the problems with current approaches to
`gene therapy,” Dr. Rothmansays.In current approaches,oncethe geneis given
`toa patientit can’t be undoneevenif it causes harm,as in the patients who
`developed cancer. In contrast, the effects of the gene pill last only a day or two,
`until the patient takes anotherpill.
`
`Experts in gene therapy say they welcomevariations on the standard approach.
`"Forrelatively small moleculeslike insulin, this should perhaps work,” says
`Katherine High, a gene-therapy pioneer and professorof pediatrics at the
`Children’s Hospital of Philadelphia.
`
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`New York, NY - A report In today's Wal! StreetJournalreports on anew
`technology now underdevelopment, aiming to deliver Injectable protein drugs EE
`using an oral "genepill’ approach [1]. Journa/staff reporter Sharon Begley
`eneeeees
`
`
`Login or register for free to unlock more Medscape content
` access to our entire network of sites and services
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`Creawetes feLinUIUyy aii ierapEUULe | 2 j SIE Wilkes, HUWUlaL HLL Only
`
`
`sihvtcantyworsenedrodadinceesedanger per
`altriakingNEOMPRshoad
`seat
`es
`LetaaRy”
`deste alts teenies ana
`do the genes survive their digestive tripintact, they also getincorporatedinto
`SendiciaeamsNneyteate
`eseaecaee eetare
`cells ofthe gut—which thenproducethehelpful proteins for the body to use.”
`inowoalregtummentadtrateatee
`monteingtentvertand oralecre
`wears een
`
`
`Theonlycells to take up the geneare thoselining the gut, and theprotein is.
`Beeches oui ne eon
`pietilnattbipeerntieiaewyactrOm
`stipeseeenn
`noreinten Sine eon
`released from thesecells into the bloodstream,shewrites. "The geneitself
`
`
`
`Spineneectnd encePee
`Sicans orcereecrayy
`stays out of the bloodstream,withthe result that it can't reachtissues where it
`mightposearisk” Begley points out. "In sometrials oftraditional gene therapy,
`in which a virusferries @ therapeutic gene into a patients cells, the virus hes
`caused dangerousInflammationor disrupted cancer-suppressing genes,
`causing two deaths and leading the Food and Drug Administration to suspend
`somegene-therapytrials in the US"
`Free Virtual Event: “Are We All Obesity Doctors Now?” GLP-1 Agonists & Your
`Practice. Register here
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`Unlimitedaccess lo our entive network of
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`
`proceeding with the commercial developmentofthe approach, she writes,
`"UCSFholds four patents on the genepill, for which it has granted anexclusive
`license to Genteric," she writes. "Dr Rothmanhasa financialstake In the closely
`hele company.
`
`Asafety advantage
`In their published research report, Rothmanet al write thatin the new
`approach, the drug givenorally Is @ DNA plasmidthat encodesfor the protein
`of interest. They showin animal experimentsthat, for example, giving the gene
`encoding forinsulin caused insulin to be secreted, and the available insulin
`reduced blood glucoselevels among diabetic animals.
`
`

`

`
`may BI
`evataledtoric lenePETCsea
`‘WhenASMmonotherapyisn'tenough
`ia
`|
`years
`
`CONSIDERADDING prctecifuratay,SUIGIOALBEHAVIORANDIDEATION
`
`
`ead
`
`Inlinived access to aur entire network of sites and services
`Login or register for free to unlock more Medscape content =D
`advantagerelative to other genetherapies. "The doseof the drug can be
`altered from day to day, and treatment can be stopped quickly if untoward side
`effects are observed’ the authors write,
`Sources
`et
`
`1, Begley S. "Genepill” offers alternativeto shots. Wai! StreetJournal, June
`21, 2005, Available at: www.wsj.com, iz
`2, Rothman S,Tseng H, Goldfine |. Oral genetherapy: A novel method for the
`manufacture and delivery of protein drugs. Diabetes Technology and
`Therapeutics 2005; 7:549-557, Available
`at:
`
`https://wwwliebertpub.com/publication.espx?pub_id-11. Abstract
`
`
`Login or register for free to unlock more Medscape content
`Log inorRegister
`
`
`(cre th Susan Jemey eneputscouinevenreplacemecians Wi TenDN AMenkeene. hit 7, 2005
`
`

`

`
`
`
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`Sicke Cell Gere Therapy
`“Truly Trensformative!
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`Structures Diabetes Pill
`Misses Weightloss
`Expectations in Mid-stageTrial
`News
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`Insurer
`for Sickle Cell Gene
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`“Gere pill’ could eventuelly
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`reports
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`"Genepill" could eventually replace injections,
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`‘ebsapibedethor ada at
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`Diabetes Technologyand Therapeutics [ 2 ], she writes, shows that "not only
`dothe genessurvive their digestivetrip Intact, they also getIncorporatedinto
`cells ofthe gut—which then producethe helpful proteins for the body to use.”
`Theenly cells to take up the gene are thoselining the gut, and the protein is
`released from these cells into the bloodstream, she writes. "The geneitself
`stays out ofthe bloodstream,with the result that it can't reachtissues where it
`mightposea risk,Begley points out."In sometrials of traditional gene therapy,
`in which a virus ferries @ therapeutic geneinto a patient's cells, the virus hes
`caused dangerous inflammation ordisrupted cancer-suppressing genes,
`causing two deaths and leading the Foad and Drug Administration to suspend
`some gene-therapytrials in the US"
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`proceeding with the commercial developmentofthe approach, she writes,
`“UCSFholds four patents onthe genepill, for which It has granted anexclusive
`license to Genteric,’ she writes. "Dr Rothman has a financial stakein the closely
`held company."
`
`Asafety advantage
`In thelr published researchreport, Rothmanet al write that in the new
`approach,the drug givenorally is 0 DNA plasmidthat encodesforthe protein
`
`

`

`ofInterest. They show In animal experiments that, for example. giving the gene
`encoding forinsulin caused insulin to be secreted, and the available insulin
`reducedblood glucose levels among diabetic animals.
`
`7
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`rgngacedar
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`oa
`CONSIDERADDING
`sicwaneinetee
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`henASmonteieenough
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`advantage relative to other genetherapies. "The doseof the drug can be
`altered from day to day, and treatmentcan be stopped quickly if untoward side
`effects are observes,’ the authors write,
`Sources
`Pt
`
`1. Begley S. (Géhe'pill" offerselternative'to/shots!| Wal! StreetJournal, June
`21, 2005. Avallable at: www.ws).com.
`lst
`2. Rothman S,Tseng H, Goldfine |. Oral genetherapy: A novel method for the
`manufacture and delivery of protein drugs. Diabetes Technology and
`Therapeutics 2005; 7:549-557, Avallable at:
`https://wwwllebertpub.com/publication.espx?pub_id=11. Abstract
`
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`Feinyur ose
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`"Truly Trensfermetive!
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`A breakthroughin the delivery of gene therapy was recently announced by Genteric, Inc. (http:/Avww.genteric.com). Called
`the ‘GenePill’, it is a technique for oral delivery of non-viral DNA. The idea behind thepill is that the gastrointestinal organs
`will convert the introduced DNAto therapeutic proteins that will be distributed naturally by the body. The companytested the
`method using DNA encoding the humaninsulin gene. Studies showed that when the engineered DNAis introduced into the
`body,it is resistant to degradation. Whentested in diabetic rats, insulin protein was produced and secreted into the blood
`stream, lowering the rats’ blood glucose levels to normal. The technology has the potential to treat a wide array of other
`diseases such as growth hormonedeficiency. SG
`
`Awhi ala infa
`
`Challengesin scaling up AAV-based gene therapy manufacturing
`Jiang ua
`Trends in Biotechnology, April 29, 2023
`In Brief * Full-Text
`* PDF
`Open Access
`
`Engineeringof efficiency-enhanced Cas9 and base editors with improved gene therapyefficacies
`Yin et al.
`Molecular Therapy, November 30, 2022
`In Brief * Full-Text
`* PDF
`
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